Central facility that communicates with portable container via mobile device

ABSTRACT

A central facility communicates with a portable container via a mobile device. A computer at the central facility receives (a) usage data, in association with identification tag information for the portable container, from the mobile device associated with the portable container, the usage data generated by a usage sensor in the portable container, (b) environmental data from the mobile device associated with the portable container, the environmental data generated by an environmental sensor, and (c) patient data from the mobile device associated with the portable container, the patient data generated by a patient sensor. The central facility computer stores the usage data, the environmental data and the patient data in a record associated with the identification tag information. The central facility computer analyzes the usage data, the environmental data and the patient data relative to a situational rule, to determine an action. The central facility computer sends (i) action data to the mobile device associated with the portable container, and (ii) notice data to a third party in accordance with a notification rule. The central facility computer stores the action data and the notice data in the record associated with the identification tag information.

BACKGROUND OF THE INVENTION

This application is a continuation of U.S. patent application Ser. No.12/319,792, filed Jan. 12, 2009, which claims priority from U.S. patentapplication Ser. No. 61/198,794, filed Nov. 10, 2008, and also claimspriority from PCT patent application Ser. No. PCT/US 07/15922, filedJul. 12, 2007, which in turn claims priority from U.S. patentapplications Ser. Nos. 11/485,820, 11/485,828 and 11/485,829, each filedon Jul. 13, 2006, and having a common inventor and assignee herewith.

The present invention relates to central facility that receives datafrom a case for containing medicament, and more particularly, is acentral facility that receives information from, and sends informationto, the case via a mobile communication device.

For medical products, such as pharmaceuticals and devices, somegovernment regulations define information about the product as beingpart of the product. Regulations from different governments mayconflict.

Certain government regulations further define the “label” for a medicalproduct as comprising certain information affixed to the product'scontainer as well as certain information accompanying the product, suchas a written sheet with usage instructions or other information.

Government regulations for medical products differ by country, and mayinclude requirements such as:

-   -   making information available in Braille or audio for blind or        partially-sighted customers,    -   providing usage instructions in particular language(s),    -   recording and reporting, within a first time period, of fatal or        life-threatening experiences with the medical product,    -   recording and reporting, within a second time period, of        serious, unexpected, adverse experiences with the medical        product,    -   recording and reporting, within a third time period, of all        adverse experiences with the medical product,    -   storing, for a fourth time period, of all correspondence        relating to experiences with the medical product, and    -   ability to track a medical product through its life-cycle,        defined as all or part of manufacturing, distribution and usage.        Further, a single medical product may be subject to different        regulatory or procedural regimes, depending on how the product        is used, e.g., given by a physician, or used by a consumer at        home.

Best practices suggest that recording negative quality experiences,adverse reactions and other information associated with lot numbers orserial numbers helps focus quality initiatives.

In regions such as Europe, a medical products manufacturer ordistributor may have to comply with preparing product labels inapproximately 20 different languages.

A product distributor is a party other than the manufacturer, end user,or end user's medical services provider. Thus, a pharmacy can serve as adistributor.

Internet Publicationhttp://www.devicelink.com/pmpn/archive/98/09/005.html discloses amedical packaging system for a medical products manufacturer, whichutilizes a multilingual labeling sub-system in order to comply withEuropean multiple-language labeling requirements. The sub-system scans aroute sheet for a specific product code, and then compiles variabletext, including language(s) for labels. A medical products manufactureruses a language database, programs its printers to pull information fromthe database, and prints on packages produced from form-fill-sealmachines.

It will be appreciated that the needs and capabilities of a manufacturerare different than those of a distributor. For branded products fromcertain manufacturers that are distributed by multiple distributors,being able to prove that problem products were distributed by other thana specified distributor is of interest. Specifically, in productsliability lawsuits where it is substantially impossible to prove whichdistributor distributed the problem products, it may be the case thatliability is assigned to all distributors typically in proportion totheir market share. Thus, the distributors with the largest market sharehave an interest in proving that the problem products came fromdistributors other than themselves.

U.S. Publication No. 20030229543 to Shannon M. Zimmerman et al. relatesto centralized management of packaging data with rule-based contentvalidation, which provides an online environment whereby manufacturersmanage packaging data for their products. FIG. 14 illustratestranslations data entry window 108E of user interface 101 that allowsthe user to select one or more languages 136 for translation andprinting on a label of the packaging data. In this manner, any textprinted on the label may be multilingual. Another concern for medicalproducts is that the device be properly programmed and used. Forexample, infusion pumps should be programmed to dispense the correctdose. At present, each device has its own user interface and terminologyincluding dosing units. Further, nurses calibrate devices in differentways: manually, via monitors, or via the device itself Some hospitalsdevelop rule libraries of drug dosing units and dosage limits, and theyload the rule libraries into the devices, along with actions requiredand/or suggested if something is out of range. It has been proposed toadd monitoring and interruption capability to patient-controlledinfusion devices.

Some medical devices are too small to have barcode labels affixed to thedevice. Affixing such labels particularly increases labeling, storageand transportation costs. Some small manufacturers are unwilling toinvest in labeling systems to comply with lot and expiration barcoderequirements, or affixing radio frequency identification (RFID) tags.

It is known to print information such as a bar code with electricallyconductive ink. As used herein and in the claims, bar code refers to aconventional bar code, a data matrix, and techniques for representingprinted information in condensed form relative to alphanumeric text.

Mobile communications have been proposed in the health area. SIMpill, aSouth African firm, makes a small device that clips on to a medicationbottle and sends a text message to a central computer when the cap isremoved. If no message arrives, the central computer sends a textmessage reminder to the patient's mobile phone.

As another example, LG, a South Korean handset manufacturer, sells aphone with a built-in blood glucose meter, for use by diabetics, thattransmits readings to a computer for further analysis.

A further example is the AlleCare P3 holster for an Epipen, described atwww.allecare.com. An Epipen is an injector containing Epinephrine thatdelays anaphylactic reaction to allergy, the anaphylactic reactionpossibly leading to death. The P3 holster transmits a satellite locationsignal when the Epipen is removed therefrom. If the signal is notdeactivated within a minute, an operator notifies emergency servicesthat the user is in crisis.

Another example is U.S. Pat. No. 6,992,580, assigned to Motorola, Inc.,that discloses a portable communication device with two sensors, forsensing the user's environment and/or a biometric characteristic of theuser, such as heart rate. An example, from the automotive field, oftransmitting sensor readings in conjunction with location is the GeneralMotors OnStar system. Within seconds of a moderate to severe vehiclecrash, the vehicle's OnStar module will send a message to the OnStarCall Center (OCC) through a cellular connection, informing an advisor atthe call center that a crash has occurred. A voice connection betweenthe advisor and the vehicle occupants is established. The advisor thencan conference in 911 dispatch or a public safety answering point(PSAP), which determines if emergency services are necessary. If thereis no response from the occupants, the advisor can provide the emergencydispatcher with the crash information from the vehicle's sensing anddiagnostic module that reveals the severity of the crash. The dispatchercan identify what emergency services may be appropriate. Using theGlobal Positioning System (GPS) satellites, OnStar advisors are able totell emergency workers the location of the vehicle.

As another example, it is known to place a GPS sensor on a portablex-ray machine.

It is expected that government regulations, the needs of customers formore information, as well as the desire to provide more features tocustomers, will result in increasing demands relating to the scope andavailability of product information. For example, when customers cantrack their goods through the distribution process, the customers cantreat distributor facilities as the customers' inventory warehouses.

Accordingly, there is room for improved communication regarding thestatus of emergency devices.

SUMMARY OF THE INVENTION

In accordance with an aspect of this invention, there is provided amethod for a central facility to communicate with a portable containervia a mobile device. A computer at the central facility receives (a)usage data, in association with identification tag information for theportable container, from the mobile device associated with the portablecontainer, the usage data generated by a usage sensor in the portablecontainer, (b) environmental data from the mobile device associated withthe portable container, the environmental data generated by anenvironmental sensor, and (c) patient data from the mobile deviceassociated with the portable container, the patient data generated by apatient sensor. The central facility computer stores the usage data, theenvironmental data and the patient data in a record associated with theidentification tag information. The central facility computer analyzesthe usage data, the environmental data and the patient data relative toa situational rule, to determine an action. The central facilitycomputer sends (i) action data to the mobile device associated with theportable container, and (ii) notice data to a third party in accordancewith a notification rule. The central facility computer stores theaction data and the notice data in the record associated with theidentification tag information.

It is not intended that the invention be summarized here in itsentirety. Rather, further features, aspects and advantages of theinvention are set forth in or are apparent from the followingdescription and drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a block diagram showing product management system 10;

FIGS. 2A-2F are block diagrams showing embodiments of field device 70;

FIG. 3 is a flowchart showing pre-shipment processing;

FIG. 4 is a flowchart showing post-shipment processing;

FIGS. 5A-5D are views of a conventional dental handpiece;

FIG. 5E is a view of a handpiece with a problem indicator;

FIGS. 6A-6B are views of one embodiment of a clip-on girdle for ahandpiece;

FIGS. 7A-7B are views of another embodiment of a clip-on girdle for ahandpiece;

FIGS. 8A-8B are views of a handpiece according to the present invention;

FIGS. 9A-9B are views of a conventional sterilization pouch;

FIG. 10 is a view of an embodiment of a sterilization pouch;

FIG. 11A-11B are views of injectors according to the present invention;

FIGS. 12A-12C are views of cases according to the present invention; and

FIGS. 13A-13F are views of an another case according to the presentinvention.

DETAILED DESCRIPTION

Referring now to the drawings, and in particular to FIG. 1, there areillustrated communication network 5, product management system 10,customer 20, customer practice management system 25, shipping module 60,field device 70 and regulator 95.

Communication network 5 may be any wireline or wireless network, such asthe Internet, a private virtual network, a private dedicated network andso on. Further, communication network 5 may be embodied as a pluralityof networks, for example, a wireline data network and a wireless voicenetwork.

Product management system 10 includes communications interface 15,product information tag (PIT) preparation module 30, PIT preparationrules 35, PIT database 50, database viewer 55, report preparation module80, report preparation rules 85, and analyst 90.

Product management system 10 is embodied as a general-purpose computerprogrammed in accordance with the present description. Thegeneral-purpose computer can be one computer or many computers networkedtogether. System 10 can operate on dedicated or shared hardware, and maybe at a user's premises or available as a so-called “web service”through communication network 5 or other communication facility. Whensystem 10 is available as a web service, analyst 90 communicatestherewith via communication network 5, in similar manner as regulator95.

Customer 20 is able to communicate with product management system 10 viacommunication network 5. In some embodiments, customer 20 has a generalpurpose computing device, such as a personal computer. In otherembodiments, customer 20 has practice management system 25 which may beany conventional system for storing medical or dental patient records,modified to also store PIT and other information described below, forexample, the DENTRIX® system available from Henry Schein, Inc. A typicalpractice management system has a front-office portion for handlingappointment scheduling and payments, a mid-office portion for handlingpatient records and a back-office portion for handling diagnostic andtreatment information, as well as a patient portal enabling a patient toaccess their appointments and medical information via a communicationnetwork such as the Internet. In the examples described below, it iscontemplated that information associated with products by a productsdistributor is captured by practice management system 25 and associatedwith the appropriate patient record.

In some embodiments, practice management system 25 uses communicationnetwork 5 to provide information to product management system 10, suchas product usage and location information, and/or to receive informationfrom product management system 10, such as recommended operatinginstructions and product supply chain information.

PIT preparation module 30 is adapted to generate PITs for products inaccordance with customer order 20 and PIT preparation rules 35. Productstypically are medical or pharmaceutical supplies, such as drugs ordevices.

As used herein and in the claims, “PIT” means a record relating to aproduct that logically accompanies the product, and that may or may notphysically accompany the product in whole or in part. In contrast, a“label”, as the term is customarily used in the medical productsindustry, must physically accompany the product and include requiredstandardized information.

A PIT may be embodied in any of the following ways: (a) as a printedpaper affixed to a product or a product's container, (b) as a printedpaper accompanying a product, (c) as an electromagnetic device affixedto or accompanying a product that stores information, (d) as anelectromagnetic device affixed to or accompanying a product that enablesaccess to information stored about the product, the information beingstored in other than the electronic device that serves as the PIT, (e)combinations of the above, or (f) other configurations apparent to oneof ordinary skill. Thus, a PIT may be information associated with apaper, such as a bar code, and/or information associated with anelectronic or magnetic device.

Electronic devices suitable for a PIT include a radio frequencyidentification (RFID) tag, a “smart card” typically comprising acredit-card sized device with a processor and memory, a pattern that ismagnetically readable as a bar code, and other devices that will beapparent to those of ordinary skill in the art.

Generally, the PIT serves to uniquely identify the product relative toother products in PIT database 50.

Customer 20 provides an order that typically includes identification ofthe desired product, quantity, a ship-to address, an order date andsometimes a delivery date and/or other special instructions. Theinstructions may be provided directly or indirectly. An example ofindirect instructions is when a customer is in a country whoseregulations stipulate certain requirements; the customer is deemed tohave indirectly provided the certain requirements. The customer ordermay specify features of the product, for example, the type of container,and optional features such as stickers for patient charts, the stickersbearing product-related information, and characteristics of the patientthat affect the packaging, such as disabilities (need for Braillestickers), childproof containers and so on.

PIT preparation rules 35 include product handling information based onthe type of product, e.g., refrigerated, customer predefinedpreferences, shipping company requirements, regulatory requirements inthe country of origin, regulatory requirements in the destinationcountry, destination country characteristics such as officiallanguage(s), customs requirements, climate characteristics of theshipping path and destination (e.g., cold or hot packs needed), andspecial instructions in or related to the customer order.

The information in PIT preparation rules 35 relates to:

-   -   package layout and appearance;    -   what type of PIT or PITs should be used, i.e., sticker on        product, sticker on patient's chart, product insert, electronic        tag, bar code, device to be attached to patient, reorder        stickers or devices;    -   what historical information about the product content must be on        its PIT: lot code, manufacturer date, serial number, UPC code        and so on;    -   patient-specific requests and/or requirements, such as Braille        labels, audible label devices, childproof containers, easy-open        containers, and so on;    -   PIT information for the product container: whether refrigerated        shipping is needed, individual container, package container,        carton container, shipping pallet and so on;    -   when the product is a refill, how to reset or relabel the        refilled container;    -   associated products, e.g., syringes for fluids;    -   product trademark requirements;    -   proper representation of trademarks and associated designs in        translations (e.g., font, accompanying designs, different        trademarks in different countries);    -   promotional materials;    -   advice to include restrictions to be applied (ex: how to use,        how to distribute, how to store);    -   whether a sensor is to be applied, and what type sensor may be        appropriate;    -   training materials;    -   training schedules;    -   maintenance and repair instructions;    -   maintenance and repair schedules;    -   programming rules for the PIT, such as which phone number or        Internet protocol (IP) address to contact when triggered (see        discussion below of injector 600 and case 700), or when training        is required for an associated healthcare professional, patient        or caregiver (that is, individuals for some items should be        periodically or as-needed trained or retrained on use of the        item);    -   information related to communicating post-shipment information,        such as if a product complaint has to be forwarded within a        predetermined number of days after the complaint is received, if        the complaint should generate a warning message or a reminder to        appropriate parties such as the manufacturer;    -   repair reminders after a certain number of uses and.or elapsed        time since last repair; and    -   sending compliance and/or training reminders to patients,        medical providers and so on, as directed by manufacturers,        regulations, doctors or as requested by patients.

For example, let it be assumed that the customer order specifies that100 units of high speed dental operatory handpieces are to be sent to alocation in Moldova and are to have RFID tags with serial numbers. PITpreparation rules 35 specify that Moldova requires medical deviceinstructions to be in Russian and in French, that the manufacturer ofsuch handpiece as identified under Moldovian regulations bedeterminable, although not necessarily from the product PIT; that thecustomer wants its instruction sheets to have its name on the sheets andother monitoring information, and the instructions in German andEnglish, and its name affixed to the product itself; and that theregulatory requirements for Korea, the country of manufacture, specifythat the date of manufacture must be on the PIT for the device.

In this example, PIT preparation module 30 creates PITs having stickersto be affixed to the handpieces having the customer name and the date ofmanufacture, creates inserts on paper having instructions for use inRussian, French, German and English, and creates RFID tags andsterilization indicators to be affixed to the handpieces containing theserial number of the respective handpieces.

When PIT preparation module 30 generates PIT 40, it also generates a PITrecord and places the PIT record in PIT database 50. The PIT recordincludes at least the information provided in the PIT, and typicallyincludes additional information. The PIT record serves as an audit trailfor the past, present and future information about the product.Generally, the past information refers to the manufacturing history ofthe product, including manufacturer, product type, product serial numberand UPC code, product version number, manufacture date, expiration date(if any), previous owners of the product, whether the product has beensubject to recalls and field corrective actions, the number of previoussterilization procedures, vibration, shock, radiation, temperatureand/or humidity extremes in storage conditions, and so on. The presentinformation refers to instructions for use, which can be in one or morelanguages, or contain one or more pointers to instructional language,the present location of the product, and so on. The future informationrefers to the customer, the product's actual use, the shipper, theshipment route (if appropriate) and so on.

The customer may be a health care professional, such as a productprescriber or dispenser and/or a patient (product user) and/or apatient's caregiver.

Supply chain information refers to information relating to how a productarrived at its current location, particularly, who had possession of theproduct, when, and the conditions experienced by the product while in aparty's possession, such as ambient temperature and humidity ranges. Alocation sensing system, such as the global positioning system (GPS),can be a source of supply chain information. Information relating towhere and when a product was can be correlated with third-partyinformation such as transit route information and/or weather servicedata, to determine cumulative time that a product was outside atemperature range, ambient conditions at the time of use, and so on.

In some embodiments, the PIT record includes information provided to thecustomer, as well as information provided from the customer, or theproduct itself while in the customer's possession.

During the lifetime of the product, the definition of present and futureadapts. That is, after the product is received by the customer, theshipper becomes part of the past information. Usage and exceptionreports are then provided by the customer and/or the product, asdiscussed below.

Database viewer 55 enables a person, such as analyst 90, to view thecontents of PIT database 50. Database viewer 55 is embodied as softwarefor interacting with PIT database 50. Analyst 90 represents and suitablehardware for enabling a person to view information, such as a terminalor personal computer and/or printer. Database viewer 55 typicallyenables analyst 90 to formulate queries and apply them to PIT database50. Many commercial database packages are known and suitable, such asMicrosoft Access, MySQL, Oracle and so on.

PIT database 50 may be used for the following purposes:

-   -   to provide information to manufacturers for sales programs and        recalls,    -   to provide information for product liability lawsuits        quantifying the amount of product from a particular products        distributor involved in malfunctions and the like,    -   for data mining,    -   to project product failure rates and the need to replace the        product and/or maintain an inventory of spare replacement parts,    -   to indicate which customers to focus on based on the customer's        activity with regard to various procedures,    -   to recommend complementary or substitute products,    -   to provide different levels of customer support depending on the        value of the customer,    -   to update training, maintenance or repair instructions or        schedules,    -   to help decide where to locate sales and/or service centers,        typically near the most frequent users of products.

Shipping module 60 enables the shipping service to update the PITrecord, to indicate the present location of the product. Packagetracking services are well known, and employed by, for example, UPS,Federal Express and the United States Post Office. In some embodiments,shipping module 60 is part of system 10, and queries the shipper'spackage tracking service for the status of products in transit. Shippingmodule enables a person or system associated with a shipping service toupdate the PIT record. Additionally, if a shipper has field device 70,PIT 40 may update the PIT record.

Field device 70 enables a customer or other authorized party to access aPIT record, and to update a PIT record with usage and exceptioninformation. Each PIT record may contain not only actual product usageinformation, but also supply chain information for the product. In someembodiments, field device 70 also transmits PIT and possibly otherinformation directly to practice management system 25, so that the PITand other information can be associated with patient records, enabling apatient record to directly provide product supply chain information.FIGS. 2A-2F show embodiments of field device 70.

Field device 70 can be located at any point along the product supplychain, including shipper premises, doctor premises and patient premises.

Usage information refers to customary activity that the product isinvolved in. For example, if the product is a device or medicine, thefact that it was subjected to temperatures above a first threshold orbelow a second threshold at any time is a usage event. If the product isa medicine, the fact that it was used (ingested, applied, etc.) by apatient on a certain date and time is a usage event. Lack of usage isalso a form of usage information. Another example of a usage event isbeing dropped.

Exception information relates to an abnormal event associated with theproduct. For example, if the product is a device, a device failure is anexception event. If the product is a medicine, a side-effect in thepatient, such as an allergic reaction, is an exception event.

In a simple case, the customer submits a usage and/or exception eventvia a written or faxed letter, possibly using a form.

FIG. 2A shows field device 70 as comprising customer personal computer(PC) 110 and printer 115. Here, the customer communicates with PITdatabase 50 via electronic mail, or via a website. In some cases, theproduct PIT may need to be updated, and the updating occurs usingprinter 115. It will be appreciated that PC 110 may be a desktop,laptop, tablet or handheld personal computer, or a personal digitalassistant, or even a cellular telephone with suitable processingability.

Field device 70 is shown coupled to communication network 5. It will beunderstood that this coupling represents a path to a central computer,such as product management system 10, and/or, in some embodiments, to alocal computer such as practice management system 25.

FIG. 2B shows field device 70 as comprising customer PC 120 andreader/writer 125. Here, the product bears or is associated withelectronic PIT 42, such as an RFID tag or smart card. Reader/writer 125reads information from electronic PIT 42, and passes the readinformation to PC 120, which in turn uses the read information to accessthe desired PIT record from PIT database 50. When PC 120 updates the PITrecord, PIT database 50, or a program running in PC 120, may updateelectronic PIT 42 accordingly.

FIG. 2C shows field device 70 as comprising PC 130 and reader/writer135. PC 130 and reader/writer 125 can communicate with each other, andeach can communicate directly with PIT database 50. Here, the productbears or is associated with electronic PIT 43 and sensor(s) 44. Sensor44 is adapted to detect regular usage events and some exception events,and to provide this information to electronic PIT 43. In someembodiments, sensor 44 also provides detected usage events and exceptionevents directly to PIT database 50, for example, via wirelesscommunication or via daily “synchronization” sessions or via as-neededsynchronization sessions. In a synchronization session, the productcommunicates with PIT database 50, generally to provide information toPIT database 50. PC 130 is able to query PIT database 50, and also toreport usage and/or exception events that are beyond the capability ofsensor 44.

For example, if the product is a dental handpiece for holding drillbits, also referred to as burrs, sensor 44 may detect temperatures overa high threshold, such as 220° F., indicating that the handpiece hasbeen subjected to a sterilization procedure; and also may detecttemperatures under a low threshold, such as 40° F., indicating that thehandpiece has been subjected to a lubrication procedure. That is,handpiece lubrication is often performed using a spray having apropellant that creates low temperatures.

As another example, high value implants such as heart pacemakers,titanium posts screwed into bones, dental implants, artificial knees andthe like may have an embedded sensor that can be wirelessly read, incombination with a product information tag, to provide device status.

FIG. 2D shows field device 70 as comprising cellphone 140. Here, thecustomer uses cellphone 140 to call system 10 and verbally inquire aboutthe PIT record and/or verbally provide a usage and/or exception event.Security measures may be employed, such as ensuring that the callingcustomer is actually the customer to whom the product was shipped.

Cellphone 140 may have a camera and/or location sensing ability, such asGPS capability. When this is the situation, cellphone 140's features maybe used in data collection and reporting, such as usage or exceptionevetns.

FIG. 2E shows field device 70 comprising cellphone 141 and sensor 142that automatically places a call to provide sensed information. In otherembodiments (not shown) field device 70 comprises a multi-media device,able to send and receive video and audio information, and also data, andpossibly able to print data. When field device 70 is a multi-mediadevice, the PIT information may comprise multi-media. For example, theusage instructions may be a video with closed-caption text and audio,explaining how to use the medical product. This form of presentation isparticularly helpful for handicapped and/or illiterate people.

Field device 70 may be a programmable infusion pump for providing adrug. Typically, an infusion pump is programmed to provide a quantity ofdrug based on the bodyweight of the patient, sometimes with the abilityfor a patient to manually request more drug up to a predeterminedmaximum amount. The usage pattern of this device, combining itsprogramming and the patient's manual requests, can be captured as partof a clinicial trial, to correlate usage to outcome.

Similarly, for a dental restoration (filling), the usage of acombination of devices, e.g., a composite resin or other restorativematerial and at least one of a desterilizer, bonding agent, dentaldrill, laser apparatus and etchant, can be correlated with the clinicalrecord and the patient outcome, to identify best usage techniques. Ingeneral, when a combination of medical devices and/or drugs are usedtogether, it is helpful to know of the concurrent usage.

FIG. 2F shows field device 70 comprising internal communication network148, PIT 149, device 150, sensor 151, display 152, remote interface 153,local interface 154, processor with memory 155, and location assembly156. Internal communication network 148 may be a bus or a plurality ofpoint-to-point connections. Sensor 151 senses at least one operatingcondition of device 150. In one instance, device 150 is a dentalhandpiece, and sensor 151 is a bimetallic sensor that disengages one ormore burr-moving elements of the handpiece when a predeterminedtemperature is reached, to prevent overheating, as shown in more detailin FIG. 8A below. Audiovisual display 152 displays an indication of theoperating condition of device 150 to its user, such as a dentist. Whensensor 151 is triggered into sensing an event, either by usage of device150 or by a poll received from remote interface 153 or local interface154, sensor 151 activates location assembly 156 to communicate withlocation network 7, such as the global positioning system, to obtain thelocation of device 150 as a location stamp. Processor with memory 155stores readings from sensor 151 in association with a time stamp and thelocation stamp, and provides the stored sensor readings and associatedtime stamp and location stamp to one or both of remote interface 153 andlocal interface 154, for transmission to product management system 10and practice management system 25, via remote communication network 5and local communication network 6, respectively.

The device of FIG. 11 is an embodiment of the configuration of FIG. 2F.

In some embodiments, a biometric reader, such as a fingerprint reader,voice recognizer, retinal scanner or the like, is used to determine whois using device 150, and/or the identity of the patient receivingservices via device 150. In other embodiments, a barcode scanner is usedto input the identity of the user and/or patient. The identityinformation is typically associated with the PIT information in practicemanagement system 25, but may be anonymized or absent from productmanagement system 10 due to privacy concerns.

In some embodiments, interfaces 153, 154 and processor with memory 155are in a cradle that device 150 having sensor 151 is placed into.

In combination with the PIT information, the sensor readings areanalyzed to assess the cause for unexpected failure of a device or classof devices. Analysis occurs as product management system 10, practicemanagement system 25, field device 70, or combinations thereof. A causeof failure may include usage patterns. Such assessment could be thebasis for notifying the operator of a potential problem, offeringmaintenance training to operators predicting future product failures,and avoiding product liability.

One of the concerns of dentists in using certain light cured materials,such as material used to fill a tooth cavity, is the degree of cureaccomplished during curing. To measure the amount of curing, a sensor issupplied with or built into the formulation of such light curedmaterial.

An example of a sensor supplied with the material is a membraneradiometer placed proximal to the material, between the material onand/or in the tooth and the light source that measures the amount oflight reaching the material, estimates therefrom the amount of curingand indicates when the estimated amount of curing (or amount of light)has reached a predetermined threshold. Another example of a sensorsupplied with the material is an external transducer for measuring thehardness of the cured material.

An example of a sensor built into the light cured material is a materialthat changes color when a certain temperature is reached. Anotherexample of a built-in sensor is a tiny transducer that measures pressurechange, indicating the hardness of the cured material.

In some cases, multiple sensors are simultaneously operative. Forexample, device 150 may be a pouch that an instrument is placed into,and then the pouch is placed in a sterilization device, such as anautoclave, an oven or other device, to raise the contents of the pouchto a sterilization temperature. Here, the pouch has a sensor, theinstrument has a sensor, and the sterilization device has a sensor. Oneexample of a pouch sensor is an ink that changes color based on itstemperature. Another example of a pouch sensor is a so-called integratorink that changes color based on the amount of time it has been at orabove a temperature threshold and a predefined relative humidity. Pouchsensors can include chemical, optical, electronic, mechanical, orelectromechanical devices, and so on.

FIG. 3 is a flowchart showing pre-shipment processing.

At step 205, a customer order is received. At step 210, PIT preparationmodule 30 retrieves PIT preparation rules from PIT preparation rules 35.At step 215, module 30 creates PITs in accordance with the customerorder and PIT preparation rules. At step 220, module 30 creates a PITrecord in PIT database 50.

FIG. 4 is a flowchart showing post-shipment processing.

In one scenario, at step 305, a PIT record is accessed, via databaseviewer 55 or field device 70. The requested record is provided, andprocessing is complete.

In another scenario, at step 310, a usage event is written to a PITrecord. The usage event may be provided via field device 70, or manualinput (not shown) corresponding to the situations where the usage eventis provided via telephone, fax or paper mail.

In another scenario, at step 315, an exception event is written to a PITrecord. The exception event may be provided via field device 70, ormanual input (not shown) corresponding to the situations where theexception event is provided via telephone, fax or paper mail.

In another scenario, at step 320, a trigger is received, such as aperiodic trigger corresponding to time of day/week/month, or a one-timetrigger corresponding to receipt of an exception event. At step 325,report preparation module 80 retrieves report preparation rules fromreport preparation rules 85. At step 330, module 80 retrieves one ormore PIT records. At step 335, module 80 creates report(s) 90 inaccordance with the PIT records and report preparation rules 85.

Report(s) 90 comprise:

-   -   regulatory reports, such as reports of exception events,        particularly adverse patient reactions, that may be        electronically delivered to regulator 95,    -   customer activity reports that are directed to how much and/or        how often a product is being used, typically delivered to        analyst 90,    -   repair reports in the form of reminders, return shipping        documents or the like,    -   training response reports indicating satisfactory completion of        training,    -   customer satisfaction reports that indicate problems and        customer comments both good and bad, typically delivered to        analyst 90, and    -   re-order reports that are automatically generated as a product        is used up or reaches the end of its lifetime and are        electronically delivered to customer 20.        Report(s) 90 are based on data collected from and/or in        association with PIT 40 while the product associated with PIT 40        is possessed by the product distribution, and other parties        having possession of the product subsequent to the product        distributor, including the shipper, the medical services        provider such as doctor or dentist, and perhaps the ultimate        patient.

To a distributor, an important piece of information is the customer'sprobable need or desire to reorder. Some distributors sell or supplyscanners to customers, the scanners are for reading barcode labelsidentifying the products, so that reordering is accomplished viascanning Typically, the barcode is unique to each manufacturer andcarries the manufacturer's part number. Some distributors also affixtheir own bar code labels to a product, so that the product has two barcode labels, one from the manufacturer and the other from thedistributor. In some cases, the customer, such as a large hospital chainor a dental school, may also affix its own bar code label to theproduct, so that the product has three bar code labels. Since thevarious bar code labels use different formats, depending on the sourceof the label, it is helpful to have an automated translation tablebetween the various bar codes, to ensure, inter alia, that a product isproperly recognized.

With suitable access authorization, analyst 90 can update PITpreparation rules 35 and report preparation rules 85.

A handpiece is a unit, typically used in the medical and dentalprofessions, that is held in the hand of the party providing services tothe target. The handpiece has a rapidly rotating member for altering thetarget, such as a patient's tooth. Each handpiece has a power source;there are three types of power sources: air turbine, electric motor andair motor. An air turbine is used in a high speed turbine handpiece. Anelectric motor or air motor is used with a gear drive handpieceattachment, such as a contra-angle attachment.

An air turbine has a rotor located in the head of the handpiece. An airturbine handpiece's rotor is usually supported on each side by abearings. When there is a problem, such as dirt build-up, the turbinetypically stops working altogether. Prior to ceasing operation, the heatcaused by the handpiece may burn a patient. Its repair cost is fairlysmall. Typically, the turbine is repaired about 6-12 times during the7-10 year life of the handpiece.

For each of the electric motor and the air motor, the motor itself isattached to the gear drive handpiece attachment at its distal end, awayfrom the burr and thus away from the patient. A drive shaft connects tothe gear drive handpiece in both air and electric driven motors. Thegear drive handpiece has a series of gears and bearings to deliverreduced, unaltered or accelerated rotational speed, or a combination ofspeeds with other movements, depending on the type of procedure to beperformed. The final gears, where the cutting burrs are attached, aresupported by multiple bearings. When there is a problem, such as damageto a part of the gear drive, dirt build-up or partial or significantbearing failure, an electric or air motor continues to apply drive thatcreates excess friction that in turn creates excess heat, and the geardrive handpiece can become so hot that the patient is burned. Anelectric or air motor by its nature applies more torque for cutting. Therepair cost of a gear drive handpiece can be up to ten times the repaircost of an air turbine rotor. An advantage of using a micro-motor (anair motor or electric motor) is that with the correct ratio, such as 1to 5 increasing speed gear ratio of a gear drive handpiece, it ispossible to reach controlled sustained speeds, such as 200 krpm, at thecutting burr with 5-6 times more torque than is possible with a highspeed turbine handpiece, which in turn provides greater control of thecutting power, decreased cutting time and better dentistry.

FIGS. 5A-5B show conventional dental handpiece 400 having head 410, stem425, handle 426, base 427, tube 428 and foot pedal 429. Head 410 isgenerally in the shape of a cylinder having face 415 and push button 405opposite face 415. Burr 420 is a removable drill bit inserted into thecenter of face 415. Burr 420 can be fluted metal or unfluted diamondparticles fused to a stainless steel shaft. Push button 405 is used torelease burr 420 from handpiece 400. Head 410 includes internal lightguide 411 terminating at light cap 412 in face 415, which serves as alight for illuminating what is being drilled by burr 420.

Handpiece 400 can be a high speed turbine handpiece or a gear drivehandpiece. A high speed turbine handpiece generally has stem 425, handle426 and base 427 formed as one unit. A gear drive handpiece generallyhas stem 425 and handle 426 formed as one unit, while base 427 is aseparate unit having a motor.

In some cases, instead of light emanating from head 410, stem 425 has aninternal light guide terminating at light cap 422, located so that lightemanating from light cap 422 illuminates what is being drilled.

In operation, a dentist actuates foot pedal 429, causing power to besupplied via tube 428 to a high speed turbine handpiece, or to an air orelectric driven micro-motor attached to a gear drive handpiece, thatcauses burr 420 to rotate. In some cases, tube 428 also supplies powerto a light source, e.g., a bulb or light emitting diode (LED), thatgenerates light transmitted through light guides inside handpiece 400.Each of a high speed turbine handpiece and a gear drive handpiece hasbearings inside its head.

FIG. 5C shows high speed turbine handpiece 430 with a turbine rotor,having head casing 431, turbine rotor 432 with bearings 432A, 432Battached on each side thereof, and back cap 433. Rotor 432 isair-driven, with speeds reaching 400,000 rpm. Air is driven into thebottom of handpiece 430, shown on the right side in the drawing. It ispossible for head casing 431 or back cap 433, that is in close proximityto the revolving rotor, to become heated by a failure or degradationevent such as the failure of the bearings, dirt, wear or mechanicaldamage such as dropping the handpiece, use of an eccentric burr, or apartial depression of the back cap by a dentist.

FIG. 5D is an exploded view of the head gear assembly of a gear drivehandpiece. Head cover 434 contains bearings 435A, 435B, washer 436,final gear drive 437, spacer 438, membrane 439 and back ring 440. Whenassembled, membrane 439 and back ring 440 form a back cap. One of thecauses of failure or degradation, generally referred together asfailure, of a handpiece is normal wear and tear. Other causes of failureof a handpiece are poor maintenance, poor cleaning, inappropriate repairand/or dropping or mis-use. In some cases, poor maintenance manifestsitself by a change in the operating characteristics of the product. Anexample of this would be the build up of heat in handpieces which havenot been properly cleaned and lubricated internally. With the movementof dental practitioners toward an electric rather than an air-poweredhandpiece, this maintenance becomes even more important. With anelectric or air powered handpiece, the electric drive motor willcontinue to move the gears even though there is a build-up of foreignmaterial within the handpiece. The foreign material will cause frictionand result in heat build-up. It has been reported that this has causedtemperatures to rise to the extent that patients have been injured.

Measuring the heat of the handpiece, and/or its vibration and/or itsspeed, is useful for detecting whether a handpiece is performingproperly. Speed can be measured indirectly through vibration or noisefrequency. Vibration can indicate rotational speed too high for a givenprocedure.

FIG. 5E shows handpiece head 414 of either a high speed turbinehandpiece or a gear drive handpiece. Handpiece head 414 is similar tohandpiece head 410, described above, except that handpiece head 414includes problem indicator 100413, such as a filter or lens betweenlight guide 411 and light cap 412. In operation, when a problem such asfailure or degradation occurs, problem indicator 100413 interferes withthe light from light guide 411, such as by changing the color of thelight or blocking the light entirely, to alert the dentist or otherhandpiece user that a problem exists.

FIGS. 6A-6B are views of girdle 450 intended to clip on to handpiece400, specifically, to wrap around handpiece head 410. Girdle 450 hasspine 451, back support 454 having flexible membrane 452, back detectionband 456 and front detection band 458. Detection band 456 has vibrationsensor 462 at one end, and temperature sensor 464 at its other end.Detection band 458 has vibration sensor 466 at one end, and temperaturesensor 468 at its other end. Sensors 462, 464, 466, 468 are generally inrespective planes orthogonal to the planes of the ends of detectionbands 458, 456; in some embodiments, the sensors are in the same planeas the detection bands. Spine 451 has product information tag 460 andsterilization sensor 469.

Girdle 450 may be formed of any suitable substance or combination ofsubstances, such as a lightweight flexible metal for detection bands456, 458, bimetallic material for sensors 464, 468 and piezoelectricmaterial for vibration sensors 462, 466. Sterilization sensor 469 may beink that changes color in response to temperature. Temperature sensors464, 468 can change shape in response to temperature, as is typical fora bimetallic material, and/or can change color. Vibration sensors 462,466 can change color in response to vibration.

Operation of girdle 450 will now be discussed.

Handpiece 400 is typically sterilized after each use. Similarly, girdle450 is sterilized after each use, such as by putting girdle 450 in anautoclave (steam sterilizer) or other device designed to sterilize, suchas an electron beam sterilizer, a gamma radiation sterilizer, orsubmersion in a liquid sterilant or an ethylene oxide sterilizer. Insome cases, sterilization raises the ambient temperature so that thetemperature on the surface of girdle 450 reaches a predeterminedtemperature, or the ambient temperature reaches a predeterminedtemperature. Sterilization sensor 469, which may be printed ink thatchanges color when the predetermined conditions have been reached,serves to verify that sterilization of girdle 450 has occurred.Sterilization sensor 469 may be reset by applying pressure thereto, orvia another suitable reset method.

After sterilization, girdle 450 is placed on head 410 so that flexiblemembrane 452 covers push button 405, back detection band 456 isgenerally over the back bearing, and front detection band 458 isgenerally over the front bearing.

Flexible membrane 452 enables the dentist to remove burr 420 fromhandpiece 400 by pressing push button 405. Flexible membrane 452 mayadvantageously block some force applied to push button 405, such as whena dentist improperly rests push button 405 against a surface, or useshandpiece 400 as a patient cheek retractor.

When handpiece 400 reaches a temperature above its normal operatingtemperature, the normal operating temperature being defined relative toeach type of handpiece, the back of head 410 typically is hottest, andthis temperature is picked up by back support 454 and communicated todetection bands 456, 458 via spine 451.

Detection band 456, being flexible, is responsive to the vibration andtemperature caused by the back bearing. When the vibration of detectionband 456 exceeds a first vibration threshold, vibration sensor 462triggers, such as by changing shape or color. When the temperature ofdetection band 456 exceeds a first temperature threshold, temperaturesensor 464 triggers, such as by changing shape or color. The triggeringof a sensor indicates to the dentist that maintenance is needed.

Handpiece vibration can be caused by a chipped, worn, damaged oreccentric burr, by faulty construction, by build-up of dirt, or byanother cause.

Detection band 458 operates in similar manner as detection band 456,except that band 458 is responsive to the front bearing.

In some embodiments, the sensor triggering is communicated to productinformation tag 460 and/or a processor or controller, such as in FIG.2C, via wireline or wireless communication. Depending on the legalregulations of the country and design factors, the processor may thencut off power to the handpiece, or otherwise disengage burr-movingelements, to ensure that the handpiece is not permitted to operate whileit is too hot, thereby preventing harm to the patient.

FIGS. 7A-7B are views of girdle 470, which is similar to girdle 450except that girdle 470 has stabilizer clip 472 at its rear, instead of aflexible membrane, and has only one sensor.

FIGS. 8A-8B are views of handpiece 490, which is generally similar tohandpiece 400. For brevity, only the differences will now be discussed.

Handpiece 490 has head 491 having built-in detection bands 492, 494,product information tag 493, temperature indicator 100496, vibrationindicator 100498, and sterilization indicator 100499. Detection bands492, 494 may be on the outside of head 491, the inside of head 491, orlocated in cut-out areas of head 491, as shown. Similar to detectionbands 456, 458, detection bands 492, 494 respectively serve to detecttemperature and vibration from the back and front bearings of handpiece490. Respective temperature and vibration sensors, similar to thosedescribed above with respect to girdle 450, are located inside head 491,and cause indicators 100496, 498 to light when appropriate thresholdsare passed. Sterilization sensor 499 is similar to sterilization sensor469 of girdle 450.

Handpiece 490 has base 443 having cords or pipes 441, 442 extendingtherefrom to a controller (not shown in FIGS. 8A-8B, but generally shownin FIG. 2C). Cords or pipes 441, 442 represent a flexible shaft and/oran air delivery mechanism and/or a electrical power connection and/or anelectrical connection for communication, depending on the type ofhandpiece. Cord 441 provides power, similar to cord 428 of handpiece400. Pipe 442 provides electrical signals from the temperature andvibration sensors of head 491, and possibly signals to and from PIT 493,as generally shown in FIG. 2C. The controller is able to terminate powerto the handpiece when the operating characteristics of the handpiece aredeemed to be unacceptable.

In some embodiments, the sensors in handpiece 490 terminate power to thehandpiece when the appropriate thresholds are passed.

In some embodiments, the user of handpiece 490 is given theopportunity—but is not required—to indicate to the controller that usageinstructions were read prior to use. The controller stores theindication, if provided, which is useful for subsequent investigationsif a problem arises with the handpiece. In other embodiments, thecontroller requires that the user of handpiece 490 certify that usageinstructions were read before enabling power to handpiece 490.

FIGS. 9A-9B are views of conventional sterilization pouch 500 havingback 505, front 510 and adhesive strip 515. Typically, back 505 isformed of paper while front 510 is formed of transparent plastic. Front510 is permanently affixed to back 505 along three edges. The unaffixededge of front 510 is opposite adhesive strip 515. When the portion ofback 505 bearing adhesive strip 515 is folded over the unaffixed edge offront 510, the unaffixed edge becomes affixed and a pouch is formed.Imprinted on the side of back 505 facing the pouch is temperature sensor520, formed of thermally sensitive ink, which changes color when apredetermined temperature is reached. On the side of back 505 outsidethe pouch is sensor 525, formed of sensitive ink in a first color, whichchanges to a second color is the presence of chemical vapor or steam,and changes to a third color in the presence of ethylene oxide.

U.S. Pat. No. 5,344,017 shows another known sterilization pouch, inwhich the equivalent of sensor 520 is encased in a diamond shape formedby affixing the back to the front along lines forming a diamond.

FIG. 10 is a view of sterilization pouch 550. Sterilization pouch 550 isgenerally similar to pouch 500, and for brevity, only differences willbe discussed.

Sterilization pouch 550 includes sensors 571, 572, 573 formed ofthermally sensitive ink that changes color when different temperaturethresholds t₅₇₁, t₅₇₂, t₅₇₃ are reached. Together, sensors 571, 572, 573form an integrator. Sensors 571, 572, 572 are located behind panel 581,which ensures that the ink from the sensors does not contaminate thedevice being sterilized. In some embodiments, panel 581 is omitted.Panel 581 is typically transparent plastic. Sterilization pouch 550 alsoincludes sensors 574, 575, 576 that trigger when different temperaturethresholds t₅₇₄, t₅₇₅, t₅₇₆ are reached. Sensors 574, 575, 578 areadapted to be read either electronically, magnetically orelectromagnetically by an external sensor reader (see FIG. 2C). Sensors574, 575, 578 are located behind panel 582, which ensures that thesensors remain separate from the device being sterilized.

Sterilization pouch 550 also includes PIT 590.

As used herein and in the claims, injector refers to a syringe or anauto-injector. A syringe is a device having a fluid and a hypodermic(hollow) needle wherein manual action of the user provides force forforcing the fluid through the hypodermic needle. An auto-injector is adevice having a fluid, a spring and a hypodermic needle wherein the usermerely places the device against his or her skin to activate the unit,thereby forcing the medicament, typically a fluid but sometimes apowder, through the hypodermic needle. In some instances, anauto-injector is an air-pressure driven gun that drives medicamentthrough a device orifice into skin or onto a mucous membrane, without aneedle. Auto-injectors are well known, for example, U.S. Pat. Nos.5,092,843 and 5,354,286, having a common inventor herewith, thedisclosure of which is hereby incorporated by reference. As used herein,an auto-injector includes a compressed gas driving mechanism, a batterypowered mechanism, or other mechanism not limited to a spring.

In some situations, such as exposure to toxins, bee stings for personsallergic thereto, seizures or out-of-desirable-range levels ofbiomarkers, receiving an injection is critical for a person to stayalive. Persons at risk of such situations often carry an injector withthem, since after realizing they have been exposed to danger, they haveonly a few moments of consciousness and so it is critical that aninjector be nearby. In general, in a high threat situation with a rescuedevice, it is desirable for the rescue device, upon being used, to senda rescue signal indicating its location, so that rescue personnel canmore readily know that their services are needed and find the harmedperson. Additionally, for persons who should be carrying a rescuedevice, it may be desirable to remind such persons if their rescuedevice is not being carried, and/or if training is advisable. Similarconsiderations exists for caregivers of at-risk persons.

FIG. 11A is a side view of injector 600. Injector 600 is shown as asyringe but, in other embodiments, is an auto-injector. When injector600 is used to dispense its dosage, it determines its location, andsends a message to a central facility, such as a rescue center orproduct management system 10, giving its unique identification numberand its location. The central facility uses the unique identificationnumber to determine the contents of injector 600 and thus what sort ofthreat may have occurred so that suitable rescue personnel may bedispatched. The unique identification number may also be associated witha likely user of the device, and the user's organization may be notifiedthat a problem has occurred and help is on its way. Injector 600 is anembodiment of the configuration of FIG. 2F.

Injector 600 includes housing 605, stem 610, plunger 615, movable disc620, end cap 630, dosage chamber 640, hypodermic needle 645, needle cap650, sensor 660, processor with memory 665, communications interface670, PIT 675, battery 680 and location interface 685. Dosage chamber 640is at least partially filled with rescue fluid.

When a user feels the need for rescue fluid, the user removes end cap630 and needle cap 650 from injector 600, inserts needle 645 into theuser's skin, then presses plunger 615 towards housing 605. The forceapplied to plunger 615 is transmitted to disc 620 via stem 610. Themovement of disc 620 towards needle 645 forces the rescue fluid throughneedle 645 and into the user.

Usage of an auto-injector is described in U.S. Pat. Nos. 5,092,843 and5,354,286.

Sensor 660 is inside housing 605, and is triggered by the movement ofdisc 620. In some embodiments, sensor 660 is triggered by the movementof stem 610. When sensor 660 triggers, it provides a signal to processor665 via magnetic coupling or a physical contact made through a hole inthe wall of housing 605. Processor 665 activates location interface 685to obtain the location of injector 600, such as global positioningsystem (GPS) coordinates. Processor 665 then activates communicationinterface 670, such as by initiating a cellphone call to a predeterminedtelephone number associated with a central facility, and whencommunications are established, provides a unique identification numberstored in PIT 675 along with the location from location interface 685and possibly a timestamp. In some embodiments, instead of using avoiceband cellular channel, communication interface 670 uses anemergency frequency or a control channel or another wireless channel.Battery 680 can be in a standby or non-use state until sensor 660 istriggered, and only needs to provide power for the aforementionedactivities, so battery 680 can be small. In one case, disc 620 has acoating on its backside (side away from dosage chamber 640) that coupleswith sensor 660 to provide a first resistance to processor 665; whendisc 620 is de-coupled from sensor 660 during use of injector 600,sensor 660 alone provides a second resistance to processor 665. Thechange in resistance, or the second resistance, seen by processor 665serves as the trigger signal.

FIG. 11B shows injector 600′ which is similar to injector 600 exceptthat injector 600′ is used with an external device, such as externaldevice 850 or practice management system 26, having long-rangecommunication capability and short-range communication capability, andpossibly location sensing ability and image capture ability.

Device 850, such as a cellphone or personal digital assistant, haswireless communication ability, such as cellular, via antenna 856,ability to communicate with case 800 via interface 858 operativeaccording to a short-range protocol (discussed below), a built-in GPSsensor (not shown), a built-in camera (not shown), display 855 andinformation entry means 857 such as a keypad.

Injector 600′ includes communication interface 670′ for communicatingwith device 850 via a suitable short-range communication protocol suchas Bluetooth, WiFi or other local, preferably low-power, protocol. Thecommunication protocol between injector 600′ and device 850 enablesinjector 600′ to (a) instruct device 850 to open a communication channelto the central facility, or other location, (b) send information todevice 850 for relaying to the central facility, or other location, (c)instruct device 850 to display text on display 855, such as aninstruction to a caregiver to take a picture then press * or to press #to begin and then end video streaming, (d) instruct device 850 torespond to events, such as depression of a * key, in a particularmanner, and (e) instruct device 850 to transmit information such as itsGPS coordinates to the central facility, or other location.

In some embodiments, injector 600′ communicates with practice managementsystem 26 instead of device 850. Practice management system 26 issimilar to practice management system 25, discussed above, except thatpractice management system 26 has both long-range communicationcapability and short-range communication capability. System 26'sshort-range communication capability uses antenna 27 which operatesaccording to a suitable short range protocol, such as Bluetooth or WiFi,to receive information from injector 600′. System 26's long-rangecommunication capability is via connection to communication network 5,discussed above, which is one or more networks such as wireline orwireless data or voice networks.

In operation, injector 600′ communicates information, such as its usage,to system 26 via antenna 27. System 26 then responds according to apredetermined procedure, such as alerting a private individual and/orplacing a call to an emergency provider and so on. System 26 reports thelocation of injector 600′ as being the location of system 26.

FIG. 12A shows the outside of case 700. Let it be assumed that case 700holds a medical device or drug product, such an injector. In thisembodiment, when the case is opened to remove the injector, the openingserves as the trigger signal to communicate at least one of the fact ofopening, subsequent removal, subsequent usage, and location of case 700to a central facility. Removal and use of an auto-injector can besensed, for example, when case 700 has an audio sensor for detectingdistinctive noises made by the auto-injector when it is removed and whenit is used, particularly when the auto-injector is designed to producesuch distinctive noises.

Case 700 includes lid 701, bottom part 702, top closure 703, bottomclosure 704 and electronics 705. Electronics 705 incorporates PITfunctionality, discussed above. When lid 701 is separate from bottompart 702, top closure 703 is separated from bottom closure 704. Theseparation is sensed by electronics 705, which obtains the GPS locationof case 700 and its own self-stored identification code, and initiatescommunication with a central facility as discussed above.

In other embodiments, the case may contain multiple devices, such asinjectors with different injectants, and when one of the devices isremoved, the case communicates its location to the central facility andwhich device was removed. Other examples are pills, pills in a containerthat electrically communicates when the container is removed from thecase, and a weight sensor for a multi-dose unit.

FIG. 12B shows the inside of case 700. Case 700 contains camera 706 andsensors 707, 708. Camera 706 transfers image information to electronics705, which is able to receive, store and send the image information inassociation with other information such as GPS coordinates. Accordingly,an image can be sent to the central facility to assist in verifying thata device was used, and how much of a device was used. In someembodiments, camera 706 is positionable, such as by a caregiver, toprovide a video picture or image stream of a removed auto-injectorand/or the person having a problem.

Sensors 707, 708 are chosen from a thermal image sensor, a vibrationsensor, a temperature sensor, a humidity sensor, a chemical sensor, anaudio sensor and so on. There may be multiple instance of each ofsensors 707, 708. Sensor 707 transfers information directly toelectronics 705, while sensor 708 is observed by camera 706 which inturn provides an image of sensor 708 to electronics 705. For example,sensor 708 may be paper or ink that changes color when exposed to aparticular substance or ambient condition. Accordingly, sensor readingscan be sent to the central facility.

In some embodiments, instead of being used for individual items, case700 serves as a shipping container. In these embodiments, case 700 mayreport to product management system 10 periodically, in response torequests, and/or when selected events occur.

Other emergency care devices or kits may be similar configured to reportusage, such as a cardiac defibrillator, tracheotomy device, or emergencypharmaceuticals such as so-called heart clot busters: tissue plasminogenactivator or streptokinase.

Any of the functions, such as sensing, reporting and alerting, discussedherein for an injector are also applicable to case 700, and vice-versa.

FIG. 12C shows case 800, which is similar to case 700, the differencesbeing discussed below. Similarities are not discussed for brevity.Generally, case 800 functions in similar manner as case 700, except thatcase 800 uses features of an external device, such as external device850 or practice management system 26. Device 850 and practice managementsystem 26 are described above, during the discussion of FIG. 11B.

Case 800 includes communication interface 810 for communicating withdevice 850 via a suitable protocol such as Bluetooth or other local,preferably low-power, protocol. The communication protocol between case800 and device 850 enables case 800 to (a) instruct device 850 to open acommunication channel to the central facility, or other location, (b)send information to device 850 for relaying to the central facility, orother location, (c) instruct device 850 to display text on display 855,such as an instruction to a caregiver to take a picture then press * orto press # to begin and then end video streaming, (d) instruct device850 to respond to events, such as depression of a * key, in a particularmanner, and (e) instruct device 850 to transmit information such as itsGPS coordinates to the central facility, or other location.

When the central facility is product management system 10, communicationnetwork 5 is the public switched telephone network coupled to thecellular telephone network that receives the call from processor 665 viacommunications interface 670. Communications interface 15 of productmanagement system 10 serves to receive the call and store the event ofthe call in PIT database 50. PIT database 50 includes, in the recordrelating to the injector, the contents of the injector and an identityof a person having the injector. Rules database 85 includes a rule thatwhen a call from injector 600 is received, an alert report is to beimmediately prepared and delivered to analyst 90. In some embodiments,the rule or the database record relating to the injector specifies otherparties that the alert report is to be delivered to, such as customer20. Analyst 90 then arranges for dispatching of rescue personnel to thelocation of injector 600.

In some embodiments, rules database 85 includes rules for screening thesituation, such as by a verification call to a person or device, or byinspecting an image or sensor reading, to minimize unnecessarydispatching of rescue personnel. The rules can be suggestions to analyst90, automatically applied procedures executed by product managementsystem 10, and any combination thereof.

In some embodiments, injector 600 is configured so that the centralfacility is alerted when injector 600 is not being carried by the user,and can contact the user, such as by telephone or email, to remind theuser to carry injector 600. As used herein and in the claims, detectingusage of an injector encompasses detecting when fluid is being forcedthrough the injector's hypodermic needle, and detecting when the deviceis or is not being carried by the user.

In some cases, injector 600 periodically reports its location to thecentral facility, either by initiating a location transmission orresponding to a location poll from the central facility. The centralfacility then compares at least two successive location reports todetermine whether injector 600 is moving. Lack of motion indicates thatthe user might have forgotten to carry the injector.

In some cases, injector 600 periodically checks its location, stores itscurrent location, and compares at least one of its stored previouslocations with its current location, and notifies the central facilityonly if the comparison indicates no change, that is lack of motion.

With respect to movement detection, the location sensor can use GPScoordinates or can use a local metric, such as the position of a drop offluid in a chamber, or any other metric that changes based on movementof the injector.

Telemedicine, also known as telehealth, allows patients to connectremotely with healthcare providers. As used herein, the word “patient”includes a person suffering from a disease, an otherwise healthy personwho has been subjected to a toxin such as an organophosphate poison, aclinical drug trial subject, a care giver, a good Samaritan, a firstresponder such as an emergency medical technician, and others whoadminister pharmaceuticals to themselves or others. Telemedicineprograms can improve access to care, help to ensure more timelytreatment, lower healthcare costs, improve outcomes for treatment, andimprove the information available about the patient's disease state.Telemedicine programs may also be especially important for monitoringclinical trials. Some clinical trials necessary for regulatory approvalof new medications require that the patient or a caregiver administerpharmaceuticals outside of a medical facility.

FIGS. 13A-13F, collectively referred to as FIG. 13, are views of case1000 for containing pharmaceutical substances and for communicating withsystem 10. Case 1000 is similar to case 800, and only differences arediscussed for brevity.

Case 1000 allows the patient to be connected with telehealth systemssuch as Lifeline® and others which are growing in popularity. Case 1000and components thereof may be made of any suitable material, such asinjection molded plastic, blow molded plastic, metal or other materialsor combinations of materials. Case 1000 is generally rounded so that itis not snagged on other items. In other embodiments, case 1000 is kidneyshaped so that one surface conforms to the contour of a body part suchas the thigh, or chest wall. Other conforming shapes are also possible.A distinctive shape such the kidney shape or other shapes or texturescan facilitate locating the case. This is important if the patient isvisually impaired, working in a dark environment, or if the case iscarried in a purse or backpack. One or more surfaces of case 1000 may betextured in a way to facilitate locating, orienting, or using one ormore features of the case. Case 1000 may be waterproof when closed anddesigned to float when open or when closed. Case 1000 may protect thepharmaceutical container against any potentially harmful force, materialor effect, such as mechanical shock, temperature, vibration, UV andother light, radiant energy, abrasion, piercing by sharp objects,tampering, contamination from dust, salt or moisture, which could causethe delivery system to become inoperable, or from biologicalcontaminants which could infect the patient. Case 1000 may protect thepatient or others from exposure to a toxic pharmaceutical in the case orthe needle protruding from an expended autoinjector. An autoinjector isa spring-driven syringe Case 1000 may be hermetically sealed to maintaina controlled environment. A desiccant or other environmental controlagent such as nitrogen may be placed inside case 1000. Case 1000 maycontain one or more pharmaceutical containers, such as an autoinjector,a syringe, a vial containing liquid pharmaceuticals, an inhaler, or anyof numerous types of containers for tablets, capsules, powders orointments. In some embodiments, case 1000 include a cell phone or othercommunication device.

Pharmaceutical drugs deteriorate over time at a rate often correlatedwith their exposure to temperature. Outdated pharmaceuticals are notknown to be effective and should be withdrawn when possible. Thedegradation products of some pharmaceuticals are toxic. The effect ofhigh temperature exposure (such as might be encountered by patientscarrying emergency use pharmaceuticals) on the pharmaceuticals and oncontainer and closure systems of pharmaceuticals is often not wellstudied. Contaminants may be leached into the pharmaceutical.

Clinical trial pharmaceuticals may have only limited stability datanecessitating a short time at given temperature exposures before thepharmaceuticals are replaced. It is especially difficult to follow theprescribed storage conditions for remotely administered pharmaceuticals.It is, therefore clear that both these classes of pharmaceuticals willbenefit from the temperature recording capabilities of the case. This isespecially important when the pharmaceuticals must be available in anyenvironment where the patient travels.

In some cases it is important to document non-use. For example, if apatient claimed to have suffered injury from an event related to a givena pharmaceutical and the information provided by the case demonstratedthat the pharmaceutical was not used as claimed by the patient; costlyclaims related to the purported injury could be avoided.

FIG. 13 shows cover 1001, body 1002, product name area 1003,pharmaceutical container status indicators 1004, communication statusindicator 1005, power source status indicator 1006, speaker 1007,microphone 1008, camera lens 1009, device connections 101010, test/resetswitch 1011, anchoring point 1012, bar code/RFID 1013, insert 1014,follower mechanism 1015, communication module 1016, keys 1017, secondarymedication storage compartment 1018, secondary medication 1019,information label 1020, pharmaceutical containers 1021, detachmentactuator 1022, removable belt clip 1023, power source compartment 1024,power source 1025, pharmaceutical container status indicator signalingneedle exposed 1026, used pharmaceutical containers 1027, needledeflector 1028, needle 1029, sensor 1030 to signal opening of case 1000,sensor 1031 to signal presence or absence of pharmaceutical containersin case 1000, safety pin 1032, spring 1033, deflector sensor 1034,removable lanyard 1035, mating structures 1036, camera control 1037,environmental sensor 1038, and help button 1050.

Cover 1001 serves to protect the contents inside the case. Movement ofcover 1001 may be sensed and become an event to be communicated. Thecover 1001 may be slip off or hinged to the body 1002 of the case. Theproduct name or other information 1003 may be engraved, embossed, orotherwise shown on the cover 1001, or elsewhere on the case. Thisfeature and other such features may facilitate locating, orienting orusing one or more features of the case. The cover 1001 may be opaque,translucent, or transparent. If transparent, the user would be able tovisually inspect for the presence of a pharmaceutical container and beable to visually detect certain characteristics of the pharmaceuticalcontainers.

A surface of the case which would be most readily visible, usually thefront, or another surface may have indicators to inform the user orothers of the status of the case or of the pharmaceutical containers1021 inside the case. Communication status indicator 1005 shows, forexample, whether the case is within range of the designatedcommunications device or devices, signal strength, or whether the caseis actively communicating with another device. Power source statusindicator 1006 signals the strength or remaining life of a battery orother power source.

Pharmaceutical container status indicators 1004 provide informationabout individual pharmaceutical containers. For example a pharmaceuticalcontainer status indicator 1004 may show the presence or absence of apharmaceutical container 1021 in a certain section of the case. Thepharmaceutical container status indicator 1004 may also show that apharmaceutical container 1021 has been removed and returned to the caseor the physical characteristics of a certain pharmaceutical container1021 are outside a specified range.

Communications status indicator 1005, pharmaceutical container statusindicators 1004 and power source status indicator 1006 providesinformation through different light patterns (flashing or constant forexample), through the use of multiple colors of lights, through the useof numeric displays, or other visual means. LEDs which consume low powerexist in many colors.

Speaker 1007 delivers audible information. For example when the power islow, when the case is out of range of the designated communicationsdevice, or when live or recorded messages might assist the patient orothers. Examples of messages and delivered audibly to the user include(i) a reminder to replace pharmaceutical container 1021 in case 1000,(ii) a notice that the contents of pharmaceutical container are about toexpire and so should be replaced with a fresh batch, (iii) a notice thatthe user should look into an improved pharmaceutical, (iv) a notice thatthe manufacturer of pharmaceutical container 1021 has recalled itsproduct; some of these messages may be locally generated by case 1000and some may be delivered from system 10.

Microphone 1008 allows the case to receive audible signals from the useror from a pharmaceutical container such as an autoinjector. It is knownthat various types of autoinjector may create a unique sound whenactivated. Alternatively, a pharmaceutical container 1021 might bedesigned to generate a unique sound to signal the case when thecondition or location of the pharmaceutical container 1021 is changed insome way.

Camera lens 1009 attaches to a camera which may allow patient or othersto record images to assist in diagnosing and treating the patient and inotherwise recording events related to the use of the pharmaceuticalcontainer 1021. Camera control 1037 allows the patient or others toactivate and otherwise control the camera. Camera control 1037 may havea distinctive shape to allow the user to identify it. In someembodiments, the image is transmitted to a close-by communicationsdevice such as a cell phone. This will limit the cost of the case. Inother embodiments, the case may have a monitor (not shown) on a surfaceof the case.

Device connections 1010 such as a USB port, a phone connection such asan RJ-11 jack, a connection to a wireless modem or other connection maybe positioned on the bottom of the case or elsewhere. In certainembodiments, the device connections may be used to download or uploaddata or software from or to communications devices, other medicalmonitoring devices, computers, or other devices. In certain embodimentsthe device(s) connected to the case may be powered by the case; inothers, the device(s) connected may power certain functions of the case;in others, the case could be used to connect two or more other devices.Examples of the devices which might be connected are cell phones, RF IDor barcode scanners, computers, transcutaneous stimulation devices toenhance absorption of pharmaceuticals, diagnostic devices such aselectrocardiograph devices and peak flow meters, or others.

Test/reset/control switch 1011 is on the bottom of the case orelsewhere. This test/reset/control switch 1011 may be used to manuallytest, reset or control one or more functions of the case. In someembodiments, the switch may be accessed through the use of one or morespecially shaped keys 1017, the shape of which will allow an individualwith such a key to access the switch and activate certain functions ofthe test/reset/control switch 1011. In some embodiments, multiple keyseach capable of activating different functions may be supplied for usewith the case. In others, the test/reset/control switch is at the end ofa hole through the case. In still other embodiments, there may bemultiple configurations of two or more configurations of suchtest/reset/control switches 1011.

Removable belt clip 1023 or other such attachments may be mounted on therear of the case or elsewhere on the case. In order to ensure that suchan attachment remains firmly locked on to the case a positive mechanismmay be used. Use of such a mechanism may necessitate use of a detachmentactuator 1022.

Case 1000 has anchoring point 1012 for other attachments. These otherattachments might include a removable lanyard 1035 as shown or others.Others might include a wrist strap, a belt clip, a pocket clip orothers. A case may be supplied with an array of such attachments, one ormore of which may be used by the patient or others.

The pharmaceutical container or containers 1021 carried in the case maybe different depending upon the needs of the patient or other factors.Pharmaceutical container 1021 may come from the manufacturer with abarcode or RFID chip providing information such as NDC number andexpiration date. Such information could be read by a scanner and enteredinto the communications module 1016. In order to facilitate use of thecase with multiple types of pharmaceutical containers, the case mayfeature an insert 1014 made of a resilient or rigid material whichconforms essentially to the shape of the pharmaceutical container orotherwise holds the container. The insert 1014 may be removable so thatit could be replaced with another insert of the same or out a differenttype.

Case 1000 has communications module 1016 adapted to the requirements ofthe pharmaceutical product and in some cases to the requirements of thespecific patient. The requirements for the communications module maychange over time depending upon the pharmaceutical carried in the caseand upon the individual patient. Many of the communications functions ofthe case are discussed above. The proximity of the case to anothercommunications device can also be determined by another device or by thecommunications module. The communications module 1016 may bereprogrammed in situ, may be removed and modified by reprogramming orotherwise or may be replaced with a different communications module. Thecommunications module 1016 may contain an active or passive RF ID chip.Such a chip would be read by a communications device such as a cellphone or another device. The RF ID chip in combination with thecommunications device can provide information as to the proximity of thecase to the communications device. The communications module 1016 may beactivated only when the case is opened or when other events occur, suchas the expiration of a pharmaceutical, the removal of a pharmaceuticalcontainer 1021, the re-insertion into the case of a used pharmaceuticalcontainer 1021, a mechanical shock, or other event. The communicationsmodule may also be programmed to record events and to be activeintermittently or constantly. The communications module 1016 may have aGPS chip mounted therein. The case may have a digital camera mountedtherein. In other embodiments the communication module signals anothercommunications device which has a GPS chip, digital camera, proximitysensing device or other capabilities. The communications module may alsocollect data from an environmental sensor 1038 inside the case, on theexterior of the case, or in other devices. Multiple sensors may beemployed. The environmental sensor may be mounted so as to sense one ormore conditions both inside and outside the case. The data may relate toenvironmental temperature, humidity, the condition of the patient andother variables. The communications module 1016 may store, analyze, andtransmit the data automatically or as otherwise programmed. In oneembodiment the communications module calculates the cumulative exposureto temperature in various ways. As an alternative a visually readabletemperature indicator may be placed in or on the case.

In certain embodiments the power source is activated or thecommunications module is turned on either by the opening of the cover1001, the removal of a pharmaceutical container 1021, altering the stateof the test/reset/control switch 1011 or otherwise signaling a desire toactivate the communications module.

Pharmaceutical containers 1021 may be of the EpiPen® type and are shownwith a safety pin 1032 exposed after the case cover is lifted. It isknown that removal of the safety pin 1032 arms the EpiPen autoinjector.In order to prevent premature arming, the case may be fitted with meansto lock the safety pin 1032 in place while the injector is being removedfrom the case. This might be a follower mechanism 1015 which holds thesafety pin 1032 in place until a sufficient portion of the autoinjectoris available for grasping. Certain types of autoinjectors may notrequire a follower mechanism 1015 to keep the safety pin 1032 in place.Such a follower mechanism 1015 or other means could also be used to lockthe pharmaceutical container into place. In the event such followermechanisms were used to lock a pharmaceutical container 1021 into place,it might be unlocked through a signal from a communications device. Tofurther assist in removal of the autoinjector or other pharmaceuticalcontainer 1021 an assist mechanism such as spring 1033, may be employed.

To seal the case, the body 1002 and cover 1001 may employ matingstructures 1036 as shown. Other embodiments may include the use of agasket either on the body 1002 or the cover 1001 or both.

To provide information visually or through electronically readablemeans, the case may feature an information label 1020 on the cover 1001or elsewhere. This informational label may include a bar code/RFID 1013such as a 2D bar code as shown. The informational label may include anyother electronically readable tag instead of or in addition to thebarcode/RFID 1013. The information label 1020 may contain informationspecific to the patient. The informational label 1020 may be of the selfadherent type or may be carried in a pocket similar to the structureused to contain the address label carrying the address of the owner asis often used on luggage.

Power source 1025 could be a battery, a fuel cell or other such elementfor generating power. Power source 1025, may be rechargeable. The powersource or an external power source attached to the device connections1010 powers all components and functions of the case. In otherembodiments, functions and recharging may be accomplished through theuse of a docking station requiring no device connection 1010. This wouldbe advantageous in order to insure that no liquid could penetrate theclosed case.

Secondary medications 1019 would generally be tablets or other oraldosage forms. The secondary medications may be for use in associationwith the medication in the pharmaceutical container 1021. The secondarymedication might be a medication to be used before or after use of thepharmaceutical container 1021. The secondary medication may be for usein treating the condition which necessitated the prescribing themedication in the pharmaceutical container 1021. In some situations apatient might carry an unrelated medication in the secondary medicationscompartment 1018.

The power source compartment 1025 and the secondary medication storagecompartment 1018 may be mounted in a slidable, pivoting or otherarrangement. In either case the compartments 1024, 1018 may have alocking function to avoid unwanted opening. In some cases it may beuseful to send a signal to the communications module or otherwise whensuch structures are opened.

The pharmaceutical containers 1021 may be removed and replaced in thecase. The case may feature a sensor 1030 to signal opening of case 1000,sensors 1031 to signal the presence or absence of pharmaceuticalcontainers, environmental sensor 1038 to allow recording environmentalvariables. Sensors 1030, 1031, and 1038, speaker 1007, communicationsmodule 1016, status indicators 1005, 1006, and camera control 1037 maybe powered by power source 1025 or by a power source connected to thecase through the device connections. Information from the sensors may bestored in the communications module along with the time of the sensorreading. These variables may include freezing temperatures whichexceeded a certain length of time, cumulative time at temperatures abovea certain level, mechanical shock, relative humidity, environmentalcontamination in the area of the case and the patient, or othervariables. Evaluation of these variables can be performed to assess thecondition of the pharmaceutical containers 1021 and the productscontained therein, the threat the environment poses to the patient, theneed to move the patient out of the environment. These measurementscould be used, for example, to calculate remaining shelf life ofpharmaceutical containers 1021 subjected to unusual temperatures, toassess whether a pharmaceutical container 1021 had broken and allowedliquid to escape the pharmaceutical container 1021, to assess whetherthere was an unusual heat source such as a fire in the area of the case.When the pharmaceutical container is an autoinjector, returning theautoinjector to the case can be an important step to prevent injuryresulting from contact with the exposed needle. It is important to knowif a pharmaceutical container 1021 has been removed and returned to thecase. When the pharmaceutical container is an autoinjector it isimportant to know if the autoinjector has been activated. A usedpharmaceutical container 1027 of the autoinjector type is shown. In rareinstances, autoinjectors may spontaneously activate. The patient may ormay not replace the safety pin 1032 after activating an EpiPenautoinjector. The used pharmaceutical container 1027 is shown without asafety pin.

Needle deflector 1028 made of a material such as a metal and of athickness which is not easily penetrated serves to deflect the needle1029 which protrudes from the end of an autoinjector which has beenactivated. Needle deflector 1028 may be urged toward the autoinjector byspring 1033 as shown or another mechanism. When the needle of anautoinjector is protruding, the deflector will tend to force the needleto the side, thereby making the overall effective length of theautoinjector longer than the un-activated autoinjector. This differenceand the absence of a safety pin 1032 could be visually observed througha clear cover 1001.

Alternatively, deflector sensor 1034 could sense needle 1029 contactwith the needle deflector 1028 or displacement of the pharmaceuticalcontainer 1021 or the needle deflector; and signal the state of theautoinjector by changing the state of the pharmaceutical containerstatus indicator. A structure similar to the needle deflector 1028 couldalso be used to sense the weight of the pharmaceutical container, signalan out of tolerance weight, and change the state of the pharmaceuticalcontainer status indicator. Spring 1033 may also facilitate removal ofthe pharmaceutical container after the cover 1001 is opened. Thisassumes that the combination of tolerances is such that thepharmaceutical container 1021 might compress the spring when the cover1001 of the case is closed.

Help button 1050 enables the user of case 1000 to request communicationwith a central facility. To avoid accidental actuation, it is preferredthat help button 1050 be recessed. Generally, there are three separatemechanisms for a user to request help; in some embodiments, acombination of these mechanisms are required. First, a user may speak akeyword or phrase into microphone 1008. Second, a user may press helpbutton 1050. Third, a user may press test/reset switch 1011 in adistinctive pattern, such as a short press then a long press then ashort press.

Usage examples will now be discussed.

The usage examples are directed to autoinjectors, but it should beunderstood that other pharmaceutical delivery vehicles are contemplated.

Reference to the service or system is understood to be system 10 asdescribed above.

An example with Epinephrine will now be discussed.

Epinephrine packaged in an autoinjector is the standard of care for theseverely allergic patient. Allergic reactions often progress from a mildreaction upon exposure to an allergen to a more severe reaction uponsuccessive exposures. Severe allergic reaction often progresses toanaphylaxis. Anaphylaxis causes swelling of the airway and can result insuffocation and death. The need for immediate treatment with epinephrineis therefore evident. Some 4,000,000 autoinjectors filled withepinephrine are sold per year in the US. A small amount of epinephrinedelivered rapidly can be life saving.

Studies show that patients and care givers are often not adequatelytrained to recognize anaphylaxis in the early stages of onset. Studiesalso show that, patients and caregivers are uncomfortable with how touse the autoinjector. The studies also indicate that the autoinjector issometimes not readily available when needed. These results are reportedeven though there are numerous articles, websites, training devices,videos, and training courses which are offered by the autoinjectormanufacturers, prescribing physicians, professional associations ofallergists, lay associations of those suffering from allergies andinterested parties, hospitals, schools, governmental organizations andothers.

The patient and any care giver are under extreme stress at the timetreatment of anaphylaxis is required. It is reported that theautoinjector is often not used when it should be. Sometimes theautoinjector is held inappropriately and activated in a way which leadsto an injection into an unintended and/or inappropriate site. This canbe an injection into the thumb, for example. Such an injection canitself lead to serious medical consequences including damage to thestructure of the thumb. Injection in an inappropriate site will likelylead to failure to receive a dose of epinephrine as quickly or as largeas would be the case if administered as specified into the anteriorlateral thigh. Obviously, such a faulty injection will increase add tothe already significant stress. In addition, delivery of a such a doseconfounds decisions about follow on care. This is the case since theamount actually delivered cannot be easily determined.

After a single dose is delivered, another dose may be indicated ifsymptoms persist. From the above, it is clear that there is asignificant benefit to having professional assistance in real time toprovide guidance.

While the data are clear as to the benefits of epinephrine in thesituation of anaphylaxis, there are side effects to the drug. Most arenot severe, but some are sometimes sufficiently severe to requiretreatment. Side effects include palpitations, tachycardia, sweating,nausea and vomiting, respiratory difficulty, pallor, dizziness,weakness, tremor, headache, apprehension, nervousness, and anxiety.

Overdose may cause cerebral hemorrhage resulting from a sharp rise inblood pressure. Fatalities may also result from pulmonary edema becauseof peripheral vascular constriction together with cardiac stimulation.

Instructions for the EpiPen autoinjector approved by US FDA advise thatthe patient should call 911 and seek immediate medical attention afterinjecting. US FDA states that only related to anaphylaxis to food, thereare 30,000 emergency room visits, 2,000 hospitalizations, and 150deaths. The number and cost of 911 calls and ambulance transportsrelated to food allergy is also significant. The number and costemergency room visits, hospitalizations, deaths, 911 calls and ambulancetransports related to hymenoptera sting and latex related anaphylaxis isstill to be determined. The percentages in each category that have usedan autoinjector are also still to be determined. It is clear that asystem which allows medical personnel to intervene and better manage theremote emergency delivery of pharmaceuticals has significant benefit inavoiding unnecessary healthcare expense. Beyond the direct healthcarecosts, the indirect cost of stress related disease, lost work and lostproductivity is significant.

Other monitoring devices may be connected to the case to facilitate theactions discussed above.

Case 1000 and related systems can address the needs related to managingthe treatment of anaphylaxis in the following ways:

Before treatment:

-   -   Enhance sense of confidence, empowerment and well being, Relief        of anxiety regarding readiness to treat the allergic emergency.    -   Provide immediate, real time assistance in assessing the        patient's condition.    -   Help to remind the patient or care giver to keep the        autoinjector close.    -   Help the patient or care giver locate the autoinjector when        needed.    -   Provide a means for contacting trained professionals for needed        information before or during the onset of anaphylaxis.    -   Provide information on the expiration and storage of the        autoinjector.    -   Help ensure outdated or recalled injectors are disposed of        properly and replaced timely.    -   Provide a history of the interactions related to the patient and        the autoinjectors prescribed to that patient.

At time of treatment:

-   -   Provide emergency voice, visual and data contact with trained        professionals to assure proper treatment.    -   Help ensure that a second dosing is given when appropriate and        not given when not appropriate.    -   Help reduce stress.    -   Record time, location, symptoms, changes in symptoms, adverse        reactions, severity of reactions, and progress toward resolution        of the anaphylaxis.    -   Secure professional recommendation for follow on treatment        including deciding upon need to transport.

After treatment:

-   -   Document treatment and follow up.    -   Transmit to appropriate electronic medical records.    -   Ensure expended autoinjector is appropriately maintained and        eventually disposed of to avoid injury to the patient or others.    -   Ensure that a replacement autoinjector is provided to the        patient.    -   Ensure follow up as recommended is performed.    -   Ensure added training is offered if required.    -   Facilitate accumulation of data and analysis to aid in improving        the products, services, training, readiness of responders,        disease management for the patient and for the allergic        population.

The following is an example of a use of the case containing epinephrinein an autoinjector. In this example, the EpiPen autoinjector ispharmaceutical container 1021. Nine year old Billy has a history ofreaction to peanuts. The reactions have been becoming increasingly moresevere. During the last reaction, Billy had an itch and a rash asbefore. He also had a little trouble catching his breath, but recoveredafter resting. Billy's Mom was very concerned and took Billy to anallergist after the last episode. The allergist advised that these typesof reactions could progress and could be life-threatening. He describedthe symptoms and effects of anaphylaxis, showed Billy and his Mom how touse the EpiPen and prescribed the EpiPen for Billy. Billy's Mom had theprescription filled, and trained Billy on the use of the EpiPen. Still,she was concerned. She spoke with the school nurse and was glad that thenurse knew about the benefits of carrying the EpiPen. She was concernedwhen the nurse told her about another 9 year old who had injured anotherstudent, his best friend, while showing his EpiPen to him. She fearedthat Billy or his friends might play with the EpiPen in an inappropriateway. She was concerned that Billy might not have the EpiPen with himwhen a threatening allergic reaction occurred, that Billy might notrecognize the onset of anaphylaxis in time to treat himself, mightforget how to use the EpiPen and inject himself in his thumb, etc. Sheheard about a new system which offered a case for the EpiPen which couldcommunicate with the same service her 70 year old Mother, Billy'sGrandmother, Sara. Sara subscribed to the service monitor her heartrhythm. Sara had also fallen and fractured her hip. Billy's Mom addedthe service based on system 10 immediately to a family plan offered bythe service.

The service provided case 1000 which communicated with Billy's cellphone and automatically communicated with the service when appropriate.For example, any time the cover 1001 of the case was opened or thepharmaceutical container 1021 (the EpiPen) was removed from the case,the communications module 1016 was activated and communicated withBilly's cell phone. The communications module 1016 in combination withthe Billy's 3G GPS equipped cell phone was programmed to contact theservice whenever the case was opened or a pharmaceutical container 1021was removed. The opening of the case is sensed by sensor 1030 to signalopening of case 1000 when the cover 1001 is opened. The removal of apharmaceutical container 1021 is sensed by sensor to signal presence orabsence of pharmaceutical containers 31. When a pharmaceutical container1021 is removed, pharmaceutical container status indicator 1004associated with one of the two EpiPens Billy normally carried in thecase changed from green to yellow. Communications module 1016,pharmaceutical container status indicator 1004 and sensors 1030, 1031and 1038, speaker 1007, microphone 1008, status indicators 1005, 1006,and camera control 1037 are powered by power source 1025 or by a powersource connected to the case through the device connections. Informationfrom the sensors may be stored in the communications module along withthe time of the sensor reading. When such events occurred Billy's cellphone sent the service information identifying Billy and his location.Under standing instructions, the service would then call Billy's Mom.Billy's Mom was now far more confident that her son would not be injuredor die as a result of misuse, non use or abuse of the pharmaceuticalcontainer 1021(the EpiPen).

The service contacted Billy on a schedule agreed upon by his Mom toprovide refresher training The case had been programmed with theexpiration date of the pharmaceutical container 1021 (the EpiPen) whenit was initially provided. This programming was performed using abarcode reader attached to the device connections 1010. Using thisinformation, the service provides Billy's allergist and Billy's Mom areminder to replace the EpiPen three weeks before the scheduledexpiration.

Twice in the first month of his use of the service, when Billy forgot toput the EpiPen in his backpack, the service called his cell phone toremind him to get the EpiPen before he even left his house. This wasbecause the communications module 1016 had been programmed tocommunicate when the case and Billy's cell phone became separated by adistance of more than 20′. As he went back into the house his cell phonewas able to poll an RFID chip on the case to help Billy locate the case.Had he not been able to locate the case and remain within the specifieddistance; after a programmed time interval, the service and Billy's Momwould have been contacted.

About six months after Billy first received the case, he went to abirthday party. The hostess knew about Billy's allergies, and avoidedserving peanuts. Unfortunately, some of the cookies imported from Chinawere inadequately labeled and did not show that peanut flour was used inthe manufacture. Billy ate the cookies and almost immediately developeda rash. He soon experienced a constriction of his airway.

Billy located the case in his overstuffed backpack by tactile sense. Heimmediately knew which end to open because the product name 3 wasembossed on the cover 1001. Billy opened the case and removed theEpiPen. The follower mechanism 1015 helped to insure that the safety pin1032 remained on the EpiPen and that the EpiPen was not inadvertentlyarmed while removing it from the case. Once the EpiPen was removed fromthe case, the follower mechanism fell away. Billy removed the safety pin1032 and injected himself with the EpiPen. Very quickly, his cell phonerang with a special ring tone indicating that the service was calling.By this time Billy had already successfully injected the epinephrineusing the pharmaceutical container 1021. He was a little shaken, butanswered the call. He passed the phone to the hostess. She spoke withthe service and sent a photo of Billy to the service using his cellphone. The service called Billy's Mom and his allergist's emergency callline. It seemed that Billy was OK. The service advised how to monitorBilly's condition while a video consultation with the allergist could bearranged.

Billy placed the used pharmaceutical container 1027 (the activatedEpiPen) back into the case so the now exposed needle 1029 would notpresent a potential hazard. When he did so, the needle 1029 was bent tothe side by the needle deflector 1028. This caused the deflector sensor1034 to signal pharmaceutical container status indicator 1004 to changeto the color red.

Within a short time, Billy's symptoms had completely disappeared. Theallergist decided that transport to the emergency room was not required.Billy's Mom arrived and drove Billy to the allergist's office. An examconfirmed that no further treatment was required. On the way home, Billyand his Mom stopped by their pharmacy to pick up a new EpiPen and havethe case reprogrammed. The service sent a report to the allergist whichthe allergist placed in Billy's electronic medical record. This recordwas also sent to Billy's primary care physician.

The FDA approved labeling for the EpiPen states that after use, thepatient or others should “Call 911 and seek immediate medicalattention.” This may result in the dispatch of an ambulance, transport,an emergency room admission and insurance claims for these events. Inthis example using the system avoided the potential for ambulancedispatch, transport, emergency room admission, and insurance claimsprocessing for these events. The costs of these events depend upon thespecifics of the situation including geographic location. The costs mayreach thousands of dollars per event. Avoiding these costs and thestresses associated with emergency room visits is beneficial to thepatient, caregivers, and society.

In another embodiment, the voice and video contact could be made usingcamera lens 1009, camera control 1037, speaker 1007, and microphone 1008built into the case.

An example with clinical drug trials will now be discussed.

Clinical drug trials are necessary to secure approval from regulatoryagencies for the marketing on new pharmaceuticals and new dosage formsfor known pharmaceuticals. Clinical trials are expensive and notablydifficult to manage. Clinical trials require that side effects andadverse reactions be recorded. Once a subject is enrolled in a clinicaltrial, it is important to ensure that data on each dosing is accuratelyand timely recorded. Failure to accurately record such data can lead tofailure of the pharmaceutical to gain regulatory approval. Failure tocapture results on any dosing may lead regulators to question the trial.Even if the regulators can be satisfied, failure to capture data willsurely lengthen the clinical trial, increase the cost and delay time tomarket.

Some clinical trials require remote dosing over long periods of time,and dosing on the occurrence of some event such as at the onset ofsymptoms. In these cases, it is often not feasible to have the doseadministered by a healthcare professional. In these cases, the dose mustbe administered by a care giver or the subject.

It is difficult to adequately train subjects and care givers torecognize symptoms in the early stages of onset of some conditions, toadminister the pharmaceuticals in exactly the prescribed manner, and tofully and accurately record necessary information. Subjects andcaregivers may be uncomfortable with some or many facets of therequirements. These facts are especially true if the study must run forlong periods of time, if the study requires complex dosing orrecordation, or if the dosing must be carried out in an emergencysituation. Another factor which can confound such a trial is if the doseis not readily available when needed. This would result in a dose notbeing given when required, a dose delivered later that the optimal time,and a tendency to erroneously record information. In some cases, a dosemight be delivered when not required or delivered multiple times whenonly one dosing is prescribed. Faulty dosing can itself lead to seriousmedical consequences including death. Such a faulty dosing can also addto the already significant stress. In addition, delivery of a faultydose confounds decisions about follow on care and may jeopardize theacceptability of the trial.

Several clinical trials are underway or are likely for approval of newemergency pharmaceuticals and new delivery systems for existingpharmaceuticals. Some of these are life saving pharmaceuticals inautoinjectors. There is a growing regulatory emphasis on improvingclinical trials, especially improving clinical trials of products to beused in pediatric patients.

There is a significant benefit to having professional assistance in realtime to provide guidance. Without such assistance, advice that thepatient should call 911 and seek immediate medical attention after theonset of certain side effects might be ignored. Alternatively, patientsmight seek treatment when not required.

Other monitoring devices can be connected to the case to facilitate theactions discussed above.

The case and related systems can address the needs related to managingclinical trials in the following ways:

Before dosing:

-   -   Enhance sense of confidence, empowerment and well being, Relief        of anxiety regarding readiness to dose.    -   Provide immediate real time assistance in assessing the        subject's condition.    -   Help to remind the subject or care giver to keep the dose close        at hand.    -   Help the subject or care giver locate the dose when needed.    -   Provide a means for contacting trained professionals for needed        information before or during dosing.    -   Provide information on the expiration and storage of the dose.    -   Help ensure that any outdated or recalled doses are disposed of        properly and replaced timely.    -   Provide a history of the interactions related to the subject and        the dose prescribed to that subject.

At time of dosing:

-   -   Provide emergency contact with trained professionals to assure        proper dosing.    -   Help ensure that a second dosing is given when appropriate and        not given when not appropriate.    -   Help reduce stress.    -   Record time, location, symptoms, changes in symptoms, adverse        reactions, severity of reactions, progress toward resolution of        any condition.    -   Secure professional recommendation for follow on treatment.

After dosing:

-   -   Document treatment and follow up.    -   Transmit to appropriate electronic medical records.    -   Ensure expended container is appropriately maintained and        eventually disposed of    -   Ensure that a replacement dose is provided to the subject.    -   Ensure follow up as recommended is performed.    -   Ensure added training is offered if required.    -   Facilitate accumulation of data and analysis to aid in        completing the clinical trial, improving the protocol or the        products, services, training, disease management for the subject        and for the population which is the subject of the clinical        trial.

The following is an example of a use of the case containing diazepam inan autoinjector hereafter called the DIAPen that is pharmaceuticalcontainer 1021.

Diazepam is the accepted standard of care for severe epileptic seizure.Diazepam is a controlled drug because of the potential for abuse. Theonly parenteral route of administration approved for civilian selfadministration diazepam is the rectal route. Rectal administration is anembarrassment for some people. The absorption of rectal diazepam intothe bloodstream is erratic. In this example, XYZPHARM has beenauthorized to run a clinical trial on diazepam in an autoinjector.XYZPHARM hopes to market the diazepam autoinjector as an improvementover the rectal dosage form.

Fourteen year old JJ has a history of seizure. His seizures areinfrequent, but severe. Before being enrolled in the XYZPHARM clinical,JJ was walking in a crowd with his Mom on a busy New York street. Hedropped due to a seizure and only recovered when rectal diazepam wasadministered. While JJ's Mom was administering the rectal diazepam, acrowd gathered to watch and someone in the crowd stole her purse. Thiswas a very traumatic event.

JJ's Mom was very pleased when presented with the opportunity to enrollin the XYZPHARM clinical after the last episode. The only way to runsuch a clinical is to have caregivers trained to administer diazepam atthe onset of a seizure. The XYZPHARM study coordinator carefully trainedJJ and all his care givers in how to avoid the potentiallylife-threatening issues related to seizure. He described the symptomsand affects of seizure, showed JJ and his caregivers, including theschool nurse, how to use the DIAPen. The school nurse knew about thebenefits of carrying the DIAPen since she had been an Army medic andknew of the military version of the DIAPen. Still, everyone was dulyconcerned when the nurse discussed the story about 9 year old who hadinjured another student, his best friend, while showing a similarproduct, the EpiPen to him.

The study coordinator was able to allay their concerns when he discussedthe case and system which would be used to help manage the clinical. Hedescribed and demonstrated the case and system and all their functionsin detail. He discussed the fact that each DIAPen provided would come ina case which would transmit its location to the clinical monitoring siteevery 15 minutes until opened, when opened and when the pharmaceuticalcontainer 1021 (the DIAPen) was removed from the case. The studycoordinator explained that he case automatically communicated with theclinical monitoring site at regular programmed fifteen minute intervals,when the caregiver wished to ask a question or receive added training,when an event such as dropping the case onto a concrete floor occurred.For example, any time the cover 1001 of the case was opened or thepharmaceutical container 1021 (the DIAPen) was removed from the case,the communications module 1016 was activated and communicated with theclinical monitoring site. The 3G GPS equipped communications module 1016was programmed to contact the service whenever the case was opened or apharmaceutical container 1021 was removed. The opening of the case issensed by sensor 1030 to signal opening of case 1000 when the cover 1001is opened. The removal of a pharmaceutical container 1021 is sensed bysensor to signal presence or absence of pharmaceutical containers 31.When a pharmaceutical container 1021 is removed, pharmaceuticalcontainer status indicator 1004 associated with the DIAPens which JJ andhis care givers normally carry in the cases changes from green toyellow. Communications module 1016, pharmaceutical container statusindicator 1004 and sensors 1030 1031 and 1038, speaker 1007, microphone1008, status indicators 1005, 1006, and camera control 1037 are poweredby power source 1025 or by a power source connected to the case throughthe device connections. Information from the sensors may be stored inthe communications module along with the time of the sensor reading.

When events such as the opening of the case occurred, the case sent theclinical trial monitoring site sent signals identifying JJ and hislocation. Under standing instructions, the clinical monitoring centerwould then call JJ's Mom. JJ's Mom was now far more confident that herson would not be injured or die as a result of misuse, non use or abuseof the pharmaceutical container 1021 (the DIAPen).

JJ's caregivers understood the benefits of the case since they hadexposure to similar technologies in their homes and automobiles: GPS,internet access, cell phones with video capabilities, health monitoringdevices which could automatically dial healthcare systems, etc. Thestudy coordinator described how various other monitoring andcommunications devices could be connected using the device connections1010. The study protocol specified that as soon as the diazepaminjection was given, the caregiver should plug a video recorder providedby XYZPHARM into case 1000 and record JJ's condition for 15 minutes. Thestudy coordinator advised that, depending on JJ's medical responses, theprotocol might require that other devices such as blood pressuremonitors be used. These could also be attached to the case using thedevice connections.

The clinical monitoring center contacted JJ and the care givers on aschedule through a cell phone integrated into the communications module1016 to provide refresher training Since the case had been programmedwith the expiration date of the pharmaceutical container 1021 (theDIAPen) when it was initially provided, the service provides JJ'scaregivers a reminder to replace the DIAPen three weeks before thescheduled expiration.

During the first month of his enrollment in the clinical trial one ofJJ's caregivers forgot to put the DIAPen in his backpack, the casesignaled him to remind him to get the DIAPen before he even left hishouse. This was because the communications module 1016 had beenprogrammed to communicate when the case and the caregiver's key ringbecame separated by a distance of more than 20′. As he went back intothe house the case was able to poll an RFID chip on the key ring to helpJJ's caregiver locate the case. Had he not been able to locate the caseand remain within the specified distance; after a programmed timeinterval, the clinical trial monitoring center would have beencontacted.

About six months after JJ first received the case; he suffered a seizureand fell to the ground, striking his head as he fell. JJ's caregiveropened the case and removed the DIAPen. The follower mechanism 1015helped to insure that the safety pin 1032 remained on the DIAPen andthat the DIAPen was not inadvertently armed while removing it from thecase. Once the DIAPen was removed from the case, the follower mechanismfell away. JJ's caregiver removed the safety pin 1032 and injected himwith the DIAPen. Very quickly, the case rang with a special ring toneindicating that the clinical monitoring center was calling. By this timeJJ's caregiver had already successfully injected the diazepam using thepharmaceutical container 1021. He was a little shaken, but answered thecall and attached the video camera. The caregiver spoke with theclinical monitoring center and sent a video of JJ to the service usingthe 3G cell phone integral to the communications module 1016. Theclinical monitoring center observed that while the seizure appeared tobe resolved JJ remained unresponsive and that he began bleeding from hishead. The clinical monitoring center called 911, provided JJ's location,a professional description of his symptoms and transmitted a video clipof JJ's head trauma. The clinical trial monitoring center advised thecaregiver how to attend to JJ while waiting for the paramedics toarrive. The caregiver placed the used pharmaceutical container 1027 (theactivated DIAPen) back into the case so the now exposed needle 1029would not present a potential hazard. When he did so, the needle 1029was bent to the side by the needle deflector 1028. This caused thedeflector sensor 1034 to signal pharmaceutical container statusindicator 1004 to change to the color red.

When the paramedics arrived they adjudged that JJ's head trauma requiredimmediate transport. At the hospital, JJ was treated for concussion andhis head stitched. After JJ was released, the caregiver was providedwith a new DIAPen and his case reprogrammed. The clinical monitoringcenter prepared a full report for the clinical trial records and sent areport to JJ's primary care physician which he placed in JJ's electronicmedical record.

The FDA requires that the sponsors of clinical trials keep full andaccurate records of their clinical trials. There is great emphasis oninsuring that any trials involving children be well run. In this exampleusing the system avoided the potential for error and misunderstanding inadministering and recording the results of each dosing. The costs ofsuch errors and misunderstandings depends upon the specifics of thesituation. It may be that only a small number of errors are made duringa clinical. In that event, only a few dosings might have to beeliminated from the analysis. The more dosings which are eliminated ornot given, the longer the clinical trial must run. The longer theclinical trial runs, the longer the delay in time to market. If manyerrors are made, the FDA may find the entire clinical trialunacceptable. The costs may reach millions of dollars. Avoiding thesecosts and the delay in introducing improved new medications isbeneficial to the sponsors of the clinical, the patient, caregivers, andsociety.

In this specific instance the system provided benefits in the treatmentof a medical condition unrelated to the particular clinical trial. It isknown that severe brain injury should be treated as rapidly as possibleto avoid permanent, irreversible brain damage.

An example with antidotes for organophosphate poisoning will now bediscussed.

Antidotes packaged in an autoinjector are the standard of care fororganophosphate poisoning. Such autoinjectors have been stockpiled foruse. Workers manufacturing pesticides, military personnel, emergencyresponders, and, in the event of a terrorist event, civilians may sufferorganophosphate poisoning. Organophosphate poisoning causesdeterioration of the nervous system. Control of respiration and otherfunctions is compromised. Organophosphate poisoning can result in rapiddeath. The need for immediate treatment with is therefore evident. Asmall amount of antidote delivered rapidly can be life saving. The sideeffects of antidote alone cause debilitation. Medical treatment afterorganophosphate treatment is mandatory. Medical treatment afteradministering the organophosphate antidote is highly desirable even ifthe patient has not suffered organophosphate poisoning.

At risk populations are often not adequately trained to recognize thesymptoms of organophosphate poisoning in the early stages of onset.Information from Israel during the first Gulf War showed that patientsand caregivers are uncomfortable with how to use the autoinjector. Theseresults were reported even though there were numerous articles, trainingdevices, videos, and training courses which are offered by the Israeligovernment and other interested organizations. Ensuring that theautoinjector is readily available when needed is problematic.

The patient and any care giver are under extreme stress at the timetreatment of organophosphate poisoning is required. Sometimes theautoinjector is held inappropriately and activated in a way which leadsto an injection into an unintended and/or inappropriate site. This canbe an injection into the thumb, for example. Such an injection canitself lead to serious medical consequences including damage to thestructure of the thumb. Injection in an inappropriate site will likelylead to failure to receive the dose of antidote as quickly as would bethe case if administered as specified into the anterior lateral thigh.Obviously, such a faulty injection will increase add to the alreadysignificant stress. In addition, delivery of a such a dose confoundsdecisions about follow on care. This is the case since the amountactually delivered cannot be easily determined.

After a single dose is delivered, another dose may be indicated ifsymptoms persist. Again, there is a benefit to having professionalassistance in real time to provide guidance.

While the data are clear as to the benefits of antidotes in thesituation of organophosphate poisoning, there are side effects to thedrug. The side effects are often sufficiently severe to requiretreatment.

There may be sensors in place to monitor the presence and type of toxinsin the environment. However, these sensors do nothing to advise how manyindividuals have administered antidote, where and when.

Other monitoring devices may be connected to the case to facilitate theactions discussed above.

The case and related systems can address the needs related to managingthe treatment of organophosphate poisoning in the following ways:

Before treatment:

-   -   Help manage resources such as first responders. This would        include dispatch of resources to the patient.    -   Enhance sense of confidence, empowerment and well being, Relief        of anxiety regarding readiness to treat the emergency.    -   Provide immediate, real time assistance in assessing the        patient's condition.    -   Help to remind the patient or care giver to keep the        autoinjector close.    -   Help the patient or care giver locate the autoinjector when        needed.    -   Provide a means for contacting trained professionals for needed        information before or during the onset of symptoms.    -   Provide information on the expiration and storage of the        autoinjector.    -   Help ensure that any outdated or recalled doses are disposed of        properly and replaced timely.    -   Provide a history of the interactions related to the patient and        the autoinjectors prescribed to that patient.

At time of treatment:

-   -   Help ensure that others do not inappropriately administer        antidote or otherwise act inappropriately.    -   Provide emergency contact with trained professionals to assure        proper treatment.    -   Help ensure that a second dosing is given when appropriate and        not given when not appropriate.    -   Help reduce stress.    -   Record time, location, symptoms, changes in symptoms, adverse        reactions, severity of reactions, progress toward resolution of        the symptoms.    -   Secure professional recommendation for follow on treatment        including deciding upon need to transport.    -   Assist in planning and resourcing further casualty management.

After treatment:

-   -   Document treatment and follow up.    -   Transmit to appropriate electronic medical records.    -   Ensure expended autoinjector is appropriately maintained and        eventually disposed of to avoid injury to the patient or others.    -   Ensure that a replacement autoinjector is provided to the        patient.    -   Ensure follow up as recommended is performed.    -   Ensure added training is offered if required.    -   Facilitate accumulation of data and analysis to aid in improving        the products, services, training, readiness of responders,        casualty management for the patient and for the at risk        population.

The following is an example of a use of the case containing atropine inan autoinjector hereafter called the AtroPen that is pharmaceuticalcontainer 1021. Atropine packaged in an autoinjector is the acceptedstandard of care for organophosphate poisoning. Atropine is aprescription drug with the potential for significant side effects. Inthe treatment of organophosphate poisoning it is important to have rapidtreatment. If not treated organophosphate poisoning can lead to death inminutes. PESTCHEM produces pesticides most of which haveorganophosphates as the active ingredient. PESTCHEM has a sophisticatedsafety plan which includes sensors to detect any discharges of thedeadly chemicals they process, use of gas masks, frequent training,hazmat labeling, and atropine autoinjectors housed in a cases which someworkers carry and which are stored in strategic locations around thefive acre production site for emergency use.

PESTCHEM had one incident 20 years ago wherein an employee died fromorganophosphate poisoning. Long before the incident, all employees werewell trained to administer atropine at the onset of a organophosphatepoisoning. Even though the deceased employee did not follow a number ofPESTCHEM's safety regulations and was arguably grossly negligent;PESTCHEM settled the wrongful death claim for an undisclosed sumbelieved to be over $3,000,000.

PESTCHEM significantly upgraded their procedures after settling thesuit. PESTCHEM tried to determine the best way to avoid a recurrence,but found that there was no technology which was adequate to help themmanage emergencies to their complete satisfaction. PESTCHEM can now usea system which provides much information needed to help avoid arecurrence of injury and to provide assistance when an emergency occurs.

The PESTCHEM safety officer carefully trains all employees in how toavoid the potentially life-threatening issues related to organophosphatepoisoning. He described the symptoms and affects of organophosphatepoisoning, showed employees, including the senior managers, how to usethe AtroPen. The Manufacturing vice president knew about the benefits ofcarrying the AtroPen since she had been an Army medic and knew of themilitary version of the AtroPen. Still, everyone was highly concerned atthe thought of facing an incident and injecting themselves.

The safety officer is now able to allay their concerns when he discussesthe system which would be used to help manage any incident which mightoccur. He describes and demonstrates all functions of the AtroPen, thecase and system in detail. He discusses the fact that each AtroPenprovided would come in case 1000 which would transmit its location tothe clinical monitoring site every 15 minutes after case 1000 was openedand pharmaceutical container 1021 was removed from case 1000. He coversthe facts that employees and first responders would be assisted by thefeatures of the case and system. He explains that he case automaticallycommunicates with the safety monitoring center at regular programmedfifteen minute intervals, when the employee signals that he wishes toask a question or receive added training, when an event such as droppingthe case onto a concrete floor occurs. For example, any time the cover1001 of the case is opened or the pharmaceutical container 1021 (theAtroPen) is removed from the case, the communications module 1016 isactivated and communicates with the safety monitoring center. The 3G GPSequipped communications module 1016 is programmed to contact the servicewhenever the case is opened or a pharmaceutical container 1021 isremoved. The opening of the case is sensed by sensor 1030 to signalopening of case 1000 when the cover 1001 is opened. The removal of apharmaceutical container 1021 is sensed by sensor to signal presence orabsence of pharmaceutical containers 31. When a pharmaceutical container1021 is removed, pharmaceutical container status indicator 1004associated with the AtroPen changes from green to yellow. Communicationsmodule 1016, pharmaceutical container status indicator 1004 and sensors1030, 1031 and 1038, speaker 1007, microphone 1008, status indicators1005, 1006, and camera control 1037 are powered by power source 1025 orby a power source connected to the case through the device connections.Information from the sensors may be stored in the communications modulealong with the time of the sensor reading. When selected events, such asopening cover 1001 of case 1000, occur the case sends the safetymonitoring center a signal identifying the nearest employee to the caseand the location of the case. This is possible because each employeewears a badge which contains an active RFID chip. Under standinginstructions, the safety monitoring center would then call employee'ssupervisor. Management was now far more confident that employees wouldnot be injured or die as a result of misuse, non use or abuse of thepharmaceutical container 1021(the AtroPen).

Employees understood the benefits of the case since they had exposure tosimilar technologies in their homes and automobiles. The safety officerdescribed how various other monitoring and communications devices couldbe connected using the device connections 1010. The safety protocolspecified that as soon as the atropine injection was given and theemployee was in an environment known not to be contaminated, theemployee or first responder should plug a heart rate monitor provided byPESTCHEM into the case, attach the sensor of the heart rate monitor tothe employee's finger and record employee's condition for 15 minutes.The safety officer advised that, depending on employee's medicalresponses, the protocol might require that other devices such as a videocamera be used. These could also be attached to the case using thedevice connections.

The safety monitoring center contacted employees on a regular schedulethrough a cell phone integrated into the communications module 1016 toremind them to attend refresher training Since the case had beenprogrammed with the expiration date of the pharmaceutical container 1021(the AtroPen) when it was initially provided, the service providesemployees a replacement AtroPen one week before its scheduledexpiration.

During the first month of use of the system, one of employees forgot toput the AtroPen on his belt, the case signaled him to remind him to getthe AtroPen before he even left the changing room. This was because thecommunications module 1016 had been programmed to communicate when thecase and employee's badge (both of which contained RFID chips) were notread together when the employee passes one of the readers locatedthroughout the PESTCHEM site. PESTCHEM had placed such readers at theexit of each changing room. Had he not been able to locate the case andleft the changing room without it, the safety officer would have beencontacted.

In one instance, the environmental sensor 1038 detected a sudden rise inthe temperature of a case which was stored in a sensitive area of thePESTCHEM factory. The safety officer sent a first responder to the siteof the case. The first responder discovered that a small fire had brokenout in a heater for one of the mixing vessels. Had this goneundiscovered it could have resulted in a Bhopal-like event. As it was,the fire was quickly extinguished with no release of toxic materials.

About six months after employees first received the case; there was anaccidental release, a spill, of one of the organophosphate compounds.Sensors near the spill detected the spill and recorded warnings near therelease sounded loudly. The accidental release was small and an employeeacted quickly to isolate the spill. The warnings, however, were heard bya number of employees, some of whom were not near the spill. Sevenemployees in three separate locations opened the case and removed thepharmaceutical container 1021 (the AtroPen). The follower mechanism 1015helped to insure that the safety pin 1032 remained on the AtroPen andthat the AtroPen was not inadvertently armed while removing it from thecase. Once the AtroPen was removed from the case, the follower mechanismfell away. Each of the seven employees removed the safety pin 1032 andinjected himself with the AtroPen. Very quickly, the safety monitoringcenter realized that there were seven employees in three locations whohad needlessly injected themselves. In order to manage the side effectsof atropine each of the employees needed medical attention. This wasalso prudent to insure that no other employees injected unless therewere some real need to do so. The safety officer feared that, in such astressful situation, some employees might confuse the side effects ofatropine which their colleagues were experiencing with organophosphatepoisoning. Because the case had transmitted information on whichemployees had injected and their locations, the safety officer was ablesend available first responders quickly to the employees most at risk,to plan the routes of the first responders so they avoided the area ofthe initial spill until the atropine casualties were attended to. Thesafety officer called 911, gave a professional situation report andasked that they dispatch two paramedic units as a precaution. The firstresponders spoke with the safety monitoring center and sent voicemessages and a video of each of the seven employees and the three sitesto the safety officer using the video equipped 3G cell phone integral tothe communications module 1016. The safety monitoring center followedthe progress of the first responders as they moved all seven employeesto the executive conference room which had been converted to a casualtycenter in accordance with the safety plan. Paramedics were on scene inthe casualty center within minutes to treat the atropine casualties. Thefirst responders placed the used pharmaceutical container 1027 (theactivated AtroPen.) back into the case so the now exposed needle 1029would not present a potential hazard. When he did so, the needle 1029was bent to the side by the needle deflector 1028. This caused thedeflector sensor 1034 to signal pharmaceutical container statusindicator 1004 to change to the color red.

The paramedics treated each employee. One required transport to thehospital. He was a 59 year old employee with no prior reported historyof cardiovascular disease who may have suffered a coronary event. Afterall employee atropine casualties were treated, the safety officer resetthe case using three special keys 1017 which he inserted into thetest/reset/control switch 1011 of each case; placed a new AtroPen ineach case and reprogrammed the case with the expiration using a bar codescanner. The safety monitoring center prepared a full report for thesafety records and sent a report to each employee's record and, underemployees' standing permission, to each employee's primary carephysician which he placed in employees's electronic medical record.

Various agencies such as OSHA, EPA and local agencies require that theemployers keep full and accurate records regarding safety matters. Thereis great emphasis on ensuring that any facilities such as PESTCHEM whichuse or produce toxic materials are well controlled. In this exampleusing the system avoided the potential for error and misunderstanding inmanaging the emergency situation and recording the results of thoseefforts. The costs of such errors and misunderstandings depends upon thespecifics of the situation. It may be that a single, small error ismade. Even one such error can result in an expensive lawsuit. The moreerrors, the greater the chances for claims, higher premiums, regulatorycitations and fines. If many errors are made, the regulatory authoritiesmay find the entire facility unacceptable. The costs may reach millionsof dollars and even lead to bankruptcy. Avoiding the possibilities forinjury and these costs is beneficial to industry, employees and society.

The larger the site and the greater the number of casualties, thegreater the potential benefit of the system. Certain individuals such asfirst responders and those responsible for managing emergencies couldbenefit greatly from being equipped with the system.

A usage example with an asthma inhaler will now be discussed.

Asthma is one of the most common chronic diseases of childhood affectingan estimated 6 million children. Asthma is often a disease for life. Itis controlled rather than cured. Several classes of drugs are used tocontrol asthma. Short acting beta agonist (SABA), long acting betaagonist (LABA) and inhaled corticosteroids (ICS) are pharmaceuticalsoften packaged in inhalers. The generally preferred choices for thestandard of care are as follows: For intermittent asthma: SABA; Forpersistent asthma step 2: low dose ICS; For persistent asthma step 3:low dose ICS plus LABA; For persistent asthma step 4: medium dose ICSplus LABA; For persistent asthma step 5: high dose ICS plus LABA; Forpersistent asthma step 6: high dose ICS plus LABA plus oralcorticosteroid.

Failure to adequately control symptoms generally indicates a need toprogress to the next step. As asthma symptoms worsen, the dosages of thedrugs are adjusted. The drugs are beneficial and widely used, but haveside effects. In general, dosages of all pharmaceuticals should belimited to the minimum necessary to control the symptoms. Over use ofthe pharmaceuticals can be a key indicator of a worsening of theasthmatic condition. The regimen is often complicated even beforeconsideration of managing exacerbations and other medical conditions anasthma patient may suffer (co-morbidities). As the population ages, manymore in the population suffer from two or more chronic conditions.

Case 1000 can provide information and training for asthmatic patientsand their care givers. The case and related systems can address theneeds related to managing the treatment of asthma in the following ways:

Before treatment:

-   -   Enhance sense of confidence, empowerment and well being, Relief        of anxiety regarding readiness to treat the asthma emergency.    -   Provide immediate, real time assistance in assessing the        patient's condition.    -   Help to remind the patient or care giver to keep the        pharmaceuticals close.    -   Help the patient or care giver locate the pharmaceuticals when        needed.    -   Provide a means for contacting trained professionals for needed        information before or during the onset of an asthmatic        exacerbation.    -   Provide information on the expiration and storage of the        pharmaceuticals.    -   Help ensure outdated or recalled pharmaceuticals are disposed of        properly and replaced timely.    -   Provide a history of the interactions related to the patient and        the pharmaceuticals prescribed to that patient.

At time of treatment:

-   -   Provide emergency voice, visual and data contact with trained        professionals to assure proper treatment.    -   Help ensure that follow-on dosing is given when appropriate and        not given when not appropriate.    -   Help reduce stress.    -   Record time, location, symptoms, changes in symptoms, adverse        reactions, severity of reactions, and progress toward resolution        of the asthmatic exacerbation.    -   Secure professional recommendation for follow on treatment        including deciding upon need to transport.

After treatment:

-   -   Document treatment and follow up.    -   Transmit to appropriate electronic medical records.    -   Ensure expended auto pharmaceutical container is appropriately        maintained and eventually disposed of to avoid injury to the        patient or others.    -   Ensure that a replacement pharmaceutical is provided to the        patient.    -   Ensure follow up as recommended is performed.    -   Ensure added training is offered if required.    -   Facilitate accumulation of data and analysis to aid in improving        the products, services, training, readiness of responders,        disease management for the patient and for the asthmatic        population.

The following is an example of a use of the case containing acombination of pharmaceuticals in inhalers. In this example, the casecontains a Ventolin inhaler which contains albuterol (SABA) and anAdvair inhaler which contains salmeterol (LABA) and flucticasone (ICS).These would be the pharmaceutical containers 1021. A tablet of an oralcorticosteriod (OCS) is in the secondary medication storage compartment1018.

Seventeen year old Steve has a history of asthma. Steve is an activeyoung man. He is the kicker for his football team having stopped playingsoccer because of exercise induced asthma. Steve uses a SABA inhalerjust before exercise. He uses a LABA/ICS inhaler at the onset ofsymptoms. When he follows these regimes his exacerbations have neverbeen severe. Steve's last severe exacerbation resulted when he forgot tobring his inhaler to a game. During the last severe exacerbation, Stevewas in the ambulance before the inhaled medications (borrowed from afellow student) took effect. Steve's Mom was very concerned and tookSteve to his allergist again after the last episode. The allergistadvised that these types of reactions could progress and could belife-threatening. He again described the symptoms and effects of asthma,showed Steve and his Mom how and when to use the inhalers. Still,Steve's Mom was concerned. She had also spoken before with the schoolnurse and the coach were glad that they knew about the benefits of theinhalers. She was concerned when the nurse and the coach describeddifferent thoughts about when and how the inhalers should be used. Shefeared that Steve might be advised to use the pharmaceuticals in aninappropriate way. She was concerned that Steve might not have thepharmaceuticals with him when a threatening asthmatic reaction occurred,that Steve might not recognize the onset of the exacerbation in time totreat himself, might forget exactly how to use the inhalers, etc. Whenshe discussed her concerns, the allergist prescribed case 1000 forSteve. Case 1000 offered could communicate with the same service whichmonitored patients with life-threatening chronic obstructive airwaydisease and pulmonary cardiac arrhythmias.

The service set up a protocol with the allergist and trained Steve onthe use of case 1000 via the web. Case 1000 was programmed by theservice to communicate with Steve's cell phone and automaticallycommunicated with the service when appropriate. For example, when any apharmaceutical container 1021 (the inhaler) was removed from the case,the communications module 1016 was activated and recorded the removal.Steve was prompted by speaker 1007 to orally or otherwise enter a codevia microphone 1008 or otherwise each time the pharmaceutical container1021 was removed. The communications module could be programmed withvoice recognition software and other software. Information regardingthese removals and related codes would be stored in the communicationsmodule. After a number of removals with a given code or with no code,the communications module communicated with Steve's cell phone. Thecommunications module 1016 in combination with the Steve's 3G GPSequipped cell phone was programmed to contact the service whenever thepharmaceutical container 1021 was removed with a given code or withoutthe entry of a code a certain number of times. The removal of apharmaceutical container 1021 is sensed by sensor to signal presence orabsence of pharmaceutical containers 1021. When a pharmaceuticalcontainer 1021 is removed, pharmaceutical container status indicator1004 associated with one of the two inhalers Steve normally carried inthe case changed from green to yellow. Communications module 1016,pharmaceutical container status indicator 1004 and sensors 1030, 1031and 1038, speaker 1007, microphone 1008, communications module 1016,status indicators 1005, 1006, and camera control 1037 are powered bypower source 1025 or by a power source connected to the case through thedevice connections. Information from the sensors may be stored in thecommunications module along with the time of the sensor reading. Whensuch events occur Steve's cell phone sent the service informationidentifying Steve and his location. Under standing instructions, theservice would then send reports to Steve's Allergist. Steve's Mom wasnow far more confident that her son would not be injured or die as aresult of misuse, non use or abuse of the pharmaceutical container 1021(the inhaler).

The service contacted Steve on a schedule agreed upon by his allergistto provide refresher training The case had been programmed with theexpiration date and lot number of the pharmaceutical container 1021 (theinhaler) when it was initially provided. This programming was performedusing a barcode reader attached to the device connections 1010. Usingthis information and an algorithm which calculated depletion of thepharmaceutical in the pharmaceutical container based upon removals fromthe case, the service provides Steve's allergist and Steve's Mom areminder to replace the inhaler before the scheduled expiration or thedepletion of the pharmaceutical.

Twice in the first month of his use of Case 1000, when Steve forgot toput case 1000 in his backpack, his cell phone called him to remind himto get the inhalers before he even left his house. This was because thecommunications module 1016 had been programmed to communicate when thecase and Steve's cell phone became separated by a distance of more than20′. As he went back into the house his cell phone was able to poll anRFID chip on the case to help Steve locate the case. Had he not beenable to locate the case and remain within the specified distance; aftera programmed time interval, the service and Steve's Mom would have beencontacted.

About six months after Steve first received case 1000, he went on a roadgame with his football team. The game was in January in a city with ahigh elevation. Just after the kickoff, Steve when back to the bench andexperienced a severe, sudden-onset asthma exacerbation.

Steve located case 1000 case in his overstuffed backpack by tactilesense. Steve opened the case and removed the inhaler. Because of theseverity Steve voiced the words “panic attack” into the microphone 1008on case 1000. Very quickly, his cell phone rang with a special ring toneindicating that the service was calling. By this time Steve had alreadysuccessfully used his inhaler (the pharmaceutical container 1021). Hewas a little shaken, but answered the call. He passed the phone to thecoach. She spoke with the service and sent a FEV1 reading, astethoscopic recording of Steve's breathing and a photo of Steve to theservice using his cell phone. The service called Steve's his allergist'semergency call line. It seemed that Steve was OK. The service advisedthe coach how to monitor Steve's condition while a video consultationwith the allergist could be arranged. The consultation revealed thatSteve had forgotten to take his daily OCS. He removed the secondarymedication 19 (the OCS) from the secondary medication storagecompartment 1018 and took the OCS.

Steve placed the used pharmaceutical container 1027 (the activatedinhaler) back into the case. When he did so, case 1000 recorded thatthis inhaler had been associated with this event. A notice was sent toSteve's allergist.

Within a short time, Steve's symptoms had disappeared. The allergistdecided that transport to the emergency room was not required. When thebus returned to Steve's hometown, Steve's Mom picked him up and droveSteve for an exam at the allergist's office. The exam confirmed that nofurther treatment was required. The allergist used the events toreinforce the training and directed that case 1000 be programmed toprovide more frequent compliance reminders. Even though the inhalerwhich Steve had used still contained a few doses, the allergistsuggested that he retain the inhalers. Had the allergist suspected thatthe inhalers might have been defective or had there been an adversereaction, the allergist could have taken further steps to report anydefect or adverse reaction.

On the way home, Steve and his Mom stopped by their pharmacy to pick upa new inhaler and have case 1000 case reprogrammed. The service sent areport to the allergist which the allergist's practice managementsoftware placed in Steve's electronic medical record. A copy of thisupdated record was also sent to Steve's primary care physician.

The numbers of asthma-related hospital admissions and deaths shows thatbetter management could yield important savings and decreased mortality.Inadequate management such as is the case today may result in theunnecessary deaths, dispatch of an ambulance and transport, emergencydepartment visits, hospital admissions, intubations, events associatedwith hospitalization (medication errors and nosocomial infections), andinsurance claims for all these events. In this example using case 1000system avoided the potential for ambulance for all these costs. Thecosts of these events depend upon the specifics of the situationincluding geographic location. The costs may reach thousands of dollarsper event. Avoiding these costs, other indirect costs and the stressesassociated with emergency room visits is beneficial to the patient,caregivers, and society.

Although illustrative embodiments of the present invention, and variousmodifications thereof, have been described in detail herein withreference to the accompanying drawings, it is to be understood that theinvention is not limited to these precise embodiments and the describedmodifications, and that various changes and further modifications may beeffected therein by one skilled in the art without departing from thescope or spirit of the invention as defined in the appended claims.

What is claimed is:
 1. A method for a central facility to communicatewith a portable container via a mobile device, comprising: receiving, ata computer at the central facility, usage data in association withidentification tag information for the portable container, from themobile device associated with the portable container, the usage datagenerated by a usage sensor in the portable container receiving, at thecomputer at the central facility, environmental data from the mobiledevice associated with the portable container, the environmental datagenerated by an environmental sensor, receiving, at the computer at thecentral facility, patient data from the mobile device associated withthe portable container, the patient data generated by a patient sensor,storing, at the computer at the central facility, the usage data, theenvironmental data and the patient data in a record associated with theidentification tag information, analyzing, at the computer at thecentral facility, the usage data, the environmental data and the patientdata relative to a situational rule, to determine an action, sending,from the computer at the central facility, action data to the mobiledevice associated with the portable container, sending, from thecomputer at the central facility, notice data to a third party inaccordance with a notification rule, and storing, at the computer at thecentral facility, the action data and the notice data in the recordassociated with the identification tag information.
 2. The method ofclaim 1, wherein the usage data is time-stamped.
 3. The method of claim1, wherein the usage data indicates one of use of the product, non-useof the product, use of the portable container, and non-use of theportable container.
 4. The method of claim 1, wherein the usage dataindicates lack of proximity of the portable container to the mobiledevice.
 5. The method of claim 1, wherein the portable container is forcontaining at least two medications.
 6. The method of claim 1, whereinthe usage sensor senses deflection of a needle of an auto-injector. 7.The method of claim 1, wherein the usage sensor senses a number ofmedication doses remaining in the portable container.
 8. The method ofclaim 1, further comprising receiving location data associated with theusage data, the location data generated in the mobile device.
 9. Themethod of claim 1, wherein the environmental data is time-stamped. 10.The method of claim 1, wherein the environmental sensor is in one of theportable container and the mobile device.
 11. The method of claim 1,wherein the environmental data is one of location, temperature, andpressure.
 12. The method of claim 1, wherein the environmental sensorcommunicates with the mobile device.
 13. The method of claim 1, whereinthe environmental data identifies a user proximate to the container. 14.The method of claim 1, wherein the computer at the central facilitystores a set of possible users of the portable container.
 15. The methodof claim 1, wherein the patient data is time-stamped.
 16. The method ofclaim 1, wherein the patient sensor is in one of the portable containerand the mobile device.
 17. The method of claim 1, wherein the patientsensor is a help button in the portable container.
 18. The method ofclaim 1, wherein the patient data measures a human biological function.19. The method of claim 1, wherein the patient data is an image of ahuman body part.
 20. The method of claim 1, wherein the situational rulerepresents at least two of the economy, patient history, instantcondition, desired aggressiveness, sequence of medication delivery, andproduct history.
 21. The method of claim 1, wherein the action relatesto training for the medication.
 22. The method of claim 1, wherein theaction relates to replacing the medication.
 23. The method of claim 1,wherein the action relates to carrying the container.
 24. The method ofclaim 1, wherein the action relates to using a medication in thecontainer.
 25. The method of claim 1, wherein the action data is foractuating an audible signal in one of the portable container and themobile device.
 26. The method of claim 1, wherein the action datarepresents an audible signal.
 27. The method of claim 1, wherein theaction data is a text message for display by the mobile device.
 28. Themethod of claim 1, wherein the notice data is a request forintervention.
 29. The method of claim 1, wherein the third party is apractice management system.
 30. The method of claim 1, wherein thenotification rule specifies that a predetermined time has elapsed sincethe sending of the action data without a response from the mobiledevice.